Company ยท US
Tosoh Medics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2002. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 10 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 3 |
| CGN | Acid, Folic, Radioimmunoassay | 2 |
| DHX | System, Test, Carcinoembryonic Antigen | 2 |
| JZO | System, Test, Thyroid Autoantibody | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 2 |
| MMI | Immunoassay Method, Troponin Subunit | 2 |
| CDD | Radioassay, Vitamin B12 | 1 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 |
| JFT | Fluorometric, Cortisol | 1 |
| JKD | Radioimmunoassay, C-Peptides Of Proinsulin | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| JPD | Hemoglobin A2 Quantitation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2002 | K023893 | ST AIA-PACK CEA ENZYME IMMUNOASSAY Tosoh Medics, Inc. | DHX |
| Dec 17, 2002 | K023894 | ST AIA-PACK AFP ENZYME IMMUNOASSAY Tosoh Medics, Inc. | LOJ |
| Dec 17, 2002 | K023091 | ST AIA-PACK TESTOSTERONE ASSAY Tosoh Medics, Inc. | CDZ |
| Dec 6, 2002 | K023891 | ST AIA-PACK CA 125 ENZYME IMMUNOASSAY Tosoh Medics, Inc. | LTK |
| May 14, 2002 | K020489 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE Tosoh Medics, Inc. | JPD |
| Dec 14, 2001 | K012820 | AIA-PACK CTNI 2ND-GEN ASSAY Tosoh Medics, Inc. | MMI |
| Sep 18, 2001 | K011434 | G7 AUTOMATED HPLC ANALYZER Tosoh Medics, Inc. | LCP |
| Aug 16, 2001 | K010796 | AIA-PACK BRCA, ST AIA PACK BRCA Tosoh Medics, Inc. | MOI |
| Aug 10, 1999 | K992365 | AIA-PACK FOLATE ASSAY Tosoh Medics, Inc. | CGN |
| Jun 3, 1999 | K990431 | AIA-PACK CA 125 Tosoh Medics, Inc. | LTK |
| May 11, 1999 | K991252 | AIA-PACK FT3 ASSAY Tosoh Medics, Inc. | CDP |
| Dec 23, 1998 | K984359 | AIA-PACK TROPONIN I ASSAY Tosoh Medics, Inc. | MMI |
| Oct 8, 1998 | K981522 | AIA-PACK TGAB ASSAY Tosoh Medics, Inc. | JZO |
| Oct 8, 1998 | K981521 | AIA-PACK TPOAB ASSAY Tosoh Medics, Inc. | JZO |
| May 28, 1998 | K981012 | AIA-PACK MYOGLOBIN ASSAY Tosoh Medics, Inc. | DDR |
| Oct 3, 1997 | K972697 | AIA-PACK IGE II ASSAY Tosoh Medics, Inc. | DGC |
| Sep 25, 1997 | K972265 | A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER Tosoh Medics, Inc. | LCP |
| Aug 29, 1997 | K972586 | AIA-PACK TSH 3RD-GEN ASSAY Tosoh Medics, Inc. | JLW |
| Jun 27, 1997 | K971103 | AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM Tosoh Medics, Inc. | KHO |
| Jan 13, 1997 | K964348 | AIA-PACK B12 ASSAY Tosoh Medics, Inc. | CDD |
| Nov 27, 1996 | K964349 | AIA-PACK FOLATE ASSAY Tosoh Medics, Inc. | CGN |
| Nov 8, 1996 | K963687 | AIA-PACK FT3 ASSAY Tosoh Medics, Inc. | CDP |
| Feb 13, 1996 | K951848 | AIA-PACK CPR ASSAY Tosoh Medics, Inc. | JKD |
| Dec 15, 1995 | K954591 | AIA-PACK CORT ASSAY Tosoh Medics, Inc. | JFT |
| Jul 14, 1994 | K936229 | AIA-PACK TT3 ASSAY Tosoh Medics, Inc. | CDP |
| Nov 9, 1993 | K932084 | AIA-PACK E2 ASSAY Tosoh Medics, Inc. | CHP |
| Oct 22, 1993 | K933269 | AIA-PACK(R) PROG ASSAY Tosoh Medics, Inc. | JLS |
| Sep 21, 1993 | K932178 | AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES Tosoh Medics, Inc. | JJX |
| May 14, 1993 | K924859 | AIA-PACK IGE CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. | JJX |
| Mar 18, 1993 | K924857 | AIA-PACK CEA CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. | DHX |
| Mar 4, 1993 | K924860 | AIA-PACK AFP CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. | JJX |
| Jan 11, 1993 | K924856 | AIA-PACK PRL CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. | JJX |
| Jan 11, 1993 | K924852 | ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. | JJX |
| Dec 28, 1992 | K924862 | AIA-PACK HCG CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. | JJX |
| Dec 28, 1992 | K924853 | AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. | JJX |
| Dec 15, 1992 | K924858 | AIA-PACK FER CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. | DBF |
| Nov 16, 1992 | K924863 | AIA-PACK FSH CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. | JJX |
| Nov 16, 1992 | K924855 | AIA-PACK T-U CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. | JJX |
| Nov 16, 1992 | K924854 | AIA-PACK PAP CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. | JJX |
| Jan 25, 1991 | K905757 | AIA-PACK HGH Tosoh Medics, Inc. | CFL |
| Feb 26, 1990 | K900440 | AIA-PACK BMG Tosoh Medics, Inc. | JZG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||