Company ยท US
Tosoh Bioscience Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2025. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
81recalls (1 in 12 months)
43recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KHO | Fluorometer, For Clinical Use | 13 |
| JIT | Calibrator, Secondary | 8 |
| LCP | Assay, Glycosylated Hemoglobin | 7 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 5 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 4 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 3 |
| JLS | Radioimmunoassay, Progesterone | 3 |
| JZO | System, Test, Thyroid Autoantibody | 3 |
| NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | 3 |
| PDJ | Hemoglobin A1c Test System | 3 |
| CGN | Acid, Folic, Radioimmunoassay | 2 |
| CHP | Radioimmunoassay, Estradiol | 2 |
| CKG | Radioimmunoassay, Acth | 2 |
| JKD | Radioimmunoassay, C-Peptides Of Proinsulin | 2 |
| JPD | Hemoglobin A2 Quantitation | 2 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | 2 |
| MRG | System, Test, Vitamin D | 2 |
| NDY | Test, Cystatin C | 2 |
| CDD | Radioassay, Vitamin B12 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 3, 2025 | K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 Tosoh Bioscience, Inc. | PDJ |
| Nov 8, 2021 | K211199 | ST AIA-PACK BNP Assay Tosoh Bioscience, Inc. | NBC |
| Aug 5, 2021 | K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 Tosoh Bioscience, Inc. | PDJ |
| Feb 17, 2016 | K160113 | ST AIA-PACK hsE2 Calibrator Set Tosoh Bioscience, Inc. | JIT |
| Dec 18, 2015 | K153417 | ST AIA-PACK PROG III Calibrator Set Tosoh Bioscience, Inc. | JIT |
| Oct 26, 2015 | K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AI Tosoh Bioscience, Inc. | MRG |
| Jul 2, 2015 | K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set Tosoh Bioscience, Inc. | CDZ |
| Dec 16, 2014 | K143296 | AIA-PACK C-Peptide Control Set Tosoh Bioscience, Inc. | JJX |
| Dec 3, 2014 | K143144 | ST AIA-PACK PROG II Calibrator Set Tosoh Bioscience, Inc. | JIT |
| Apr 10, 2014 | K140648 | ST AIA-PACK C-PEPTIDE II CALIBRATOR SET Tosoh Bioscience, Inc. | JIT |
| Jan 23, 2014 | K131580 | AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 Tosoh Bioscience, Inc. | PDJ |
| Feb 8, 2013 | K123131 | ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI Tosoh Bioscience, Inc. | MRG |
| Jun 15, 2012 | K121533 | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET Tosoh Bioscience, Inc. | LPS |
| Dec 1, 2011 | K111335 | ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 Tosoh Bioscience, Inc. | CKG |
| Aug 5, 2011 | K111762 | ST AIA-PACK DHEA-S CALIBRATOR SET Tosoh Bioscience, Inc. | JIT |
| Sep 14, 2010 | K093960 | ST AIA-PACK CYSTATIN C, MODEL 025217 Tosoh Bioscience, Inc. | NDY |
| Aug 27, 2010 | K100304 | ST AIA PACK HBA1C Tosoh Bioscience, Inc. | LCP |
| Oct 2, 2009 | K091332 | AIA-PACK RBC FOLATE Tosoh Bioscience, Inc. | CGN |
| Sep 16, 2008 | K071132 | G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 Tosoh Bioscience, Inc. | LCP |
| Jun 21, 2007 | K063605 | ST AIA-PACK INTACT PTH ASSAY Tosoh Bioscience, Inc. | CEW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2026 | Tosoh Bioscience Inc ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204 Open, Classified |
CDZ | K023091 |
| Sep 14, 2020 | Tosoh Bioscience Inc Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy
Part number: 020661
The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ON Terminated |
JJX | None listed |
| Sep 14, 2020 | Tosoh Bioscience Inc Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG
Part number 020361
The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the Terminated |
JIT | None listed |
| May 22, 2020 | Tosoh Bioscience Inc AIA-900 Analyzer, Part no. 022930, UDI 04560189283992 Terminated |
KHO | None listed |
| Feb 11, 2020 | Tosoh Bioscience Inc AIA-360 Automated Immunoassay Analyzer, Product Code 019945 Terminated |
KHO | None listed |
| Nov 30, 2018 | Tosoh Bioscience Inc ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotropic hormone (ACTH) in human EDT A plasma. Measurem Terminated |
CKG | K111335 |
| Nov 30, 2018 | Tosoh Bioscience Inc ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Anal Terminated |
LPS | K121533 |
| Nov 30, 2018 | Tosoh Bioscience Inc ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testo Terminated |
CDZ | K023091 |
| Nov 30, 2018 | Tosoh Bioscience Inc ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specif Terminated |
CDP | K963687 K991252 |
| Nov 30, 2018 | Tosoh Bioscience Inc AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers. Terminated |
CGN | K964349 K992365 |
| Nov 30, 2018 | Tosoh Bioscience Inc AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers. Terminated |
CDD | K964348 |
| Oct 5, 2018 | Tosoh Bioscience Inc AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R
Product Usage:
The AIA-900 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoass Terminated |
KHO | None listed |
| Oct 5, 2018 | Tosoh Bioscience Inc Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation. Terminated |
LCP | K021484 |
| Oct 5, 2018 | Tosoh Bioscience Inc AIA-900 Analyzer, Product code 022930, 022930R Terminated |
KHO | None listed |
| Sep 28, 2018 | Tosoh Bioscience Inc Tosoh AIA-900 immunoassay Analyzer Terminated |
KHO | None listed |
| Sep 28, 2018 | Tosoh Bioscience Inc AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competi Terminated |
KHO | None listed |
| Sep 28, 2018 | Tosoh Bioscience Inc AIA-900Analyzer, Product code 022930, 022930R
The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a Terminated |
KHO | None listed |
| Sep 28, 2018 | Tosoh Bioscience Inc AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R
The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sand Terminated |
KHO | None listed |
| Aug 23, 2018 | Tosoh Bioscience Inc AIA-360 Analyzer, product code 019945/019945R
The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad menu of assays in a unique patented dry r Terminated |
KHO | None listed |
| Jul 13, 2018 | Tosoh Bioscience Inc G8 Automated HPLC Analyzer - 723G8
Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diag Terminated |
LCP | K131580 |
| Jun 6, 2018 | Tosoh Bioscience Inc G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674
Product Usage:
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quanti Terminated |
LCP | K100304 |
| Jun 5, 2018 | Tosoh Bioscience Inc Tosoh Bioscience AIA Analyte Application Manual (AAM) CD
Part Number: 997027
CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) f Terminated |
JIX | K111335 K121533 +2 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Cystatin C; Part Number: 025217
Assay, Kidney Marker Terminated |
NDY | K093960 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK BMG; Part Number:025259
Assay, Tumor Marker Terminated |
JZG | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK IGE II; Part Number: 025295
Assay, Allergy Terminated |
DGC | K972697 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Fer; Part Number: 025253
Assay, Anemia Terminated |
DBF | K863345 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK HGH; Part Number: 025266
Assay, Metabolic Terminated |
CFL | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Cort; Part Number: 025287
Assay, Metabolic Terminated |
JFT | K954591 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Testosterone; Part Number: 025204
Assay, Reproductive Hormone Terminated |
CDZ | K023091 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK SHBG; Part Number: 025238
Assay, Reproductive Hormone Terminated |
CDZ | K143075 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Prog II; Part Number: 025239
Assay, Reproductive Hormone Terminated |
JLS | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK LH II; Part Number: 025296
Assay, Reproductive Hormone Terminated |
CEP | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK hsE2; Part Number: 025225
Assay, Reproductive Hormone Terminated |
CHP | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Estradiol; Part Number: 025274
Assay, Reproductive Hormone Terminated |
CHP | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Prolactin; Part Number: 025255
Assay, Reproductive Hormone Terminated |
CFT | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK FSH; Part Number: 025265
Assay, Reproductive Hormone Terminated |
CGJ | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA DHEA-S; Part Number: 025222
Assay, Reproductive Hormone Terminated |
JKC | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK HCG; Part Number: 025256
Assay, Reproductive Hormone Terminated |
DHA | K863861 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK HCG; Part Number: 025261
Assay, Reproductive Hormone Terminated |
JHI | K870521 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK TU; Part Number: 025270
Assay, Thyroid Terminated |
KHQ | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK FT4; Part Number: 025268
Assay, Thyroid Terminated |
CEC | K913493 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK FT3; Part Number: 025286
Assay, Thyroid Terminated |
CDP | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK T4; Part Number: 025258
Assay, Thyroid Terminated |
KLI | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK TT3; Part Number: 025282
Assay, Thyroid Terminated |
CDP | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc AIA-PACK TSH 3rd Generation; Part Number: 020294
Assay, Thyroid Terminated |
JLW | K972586 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK IRI; Part Number: 025260
Assay, Diabetes Terminated |
CFP | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK C-Peptide II; Part Number: 025283
Assay, Diabetes Terminated |
JKD | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK C-Peptide; Part Number: 025284
Assay, Diabetes Terminated |
JKD | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK cTnI 2nd Gen; Part Number: 025205
Assay, Cardiac Marker Terminated |
MMI | K012820 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK Myoglobin; Part Number: 025297
Assay, Cardiac Marker Terminated |
DDR | K981012 |
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