Panels › Clinical Chemistry › Product code JJX · Class 1
Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation 862.1660
0510(k)s in 12 months (493 all time)
0recalls in 12 months (42 all time)
32recalls that name a 510(k)
Top companies in JJX
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Diagnostics | 60 | 0 |
| Siemens Healthcare Diagnostics | 34 | 6 |
| Boehringer Mannheim Corp. | 24 | 0 |
| Bionostics, Inc. | 22 | 0 |
| Bio-Rad | 21 | 0 |
| Ortho-Clinical Diagnostics | 13 | 3 |
| Abbott Laboratories | 4 | 9 |
| Beckman Coulter, Inc. | 9 | 4 |
| Casco Standards | 10 | 0 |
| Tosoh Medics, Inc. | 10 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 17, 1994 | K944515 | SERUM PROTEIN CONTROLS Pyramid Biological Corp. | JJX |
| Nov 15, 1994 | K944338 | DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET Casco Standards | JJX |
| Sep 9, 1994 | K942632 | TNT TROPONIN T Streck Laboratories, Inc. | JJX |
| Aug 26, 1994 | K942284 | CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET Creative Laboratory Products, Inc. | JJX |
| Aug 2, 1994 | K941433 | HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH Hichem Diagnostics | JJX |
| Jun 21, 1994 | K935611 | AXSYM LUTEINIZING HORMONE (LH) Abbott Laboratories | JJX |
| Jun 13, 1994 | K940577 | GLUCOMETER ELITE LOW CONTROL Heraeus Kulzer, Inc. | JJX |
| Jun 3, 1994 | K941130 | ASSURE URINE HCG CONTROL Quantimetrix Corp. | JJX |
| Apr 26, 1994 | K940142 | GLYCATED PROTEIN CONTROLS Primus Corp. | JJX |
| Apr 20, 1994 | K940272 | ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL Analytical Control Systems, Inc. | JJX |
| Apr 5, 1994 | K940568 | DOCUMENT(R) ZERO Casco Standards | JJX |
| Mar 22, 1994 | K935606 | SERUM AMMONIA CONTROL P.T. Meditrol, ID | JJX |
| Feb 17, 1994 | K933218 | REFRACTOMETRIC, TOTAL PROTEIN Pyramid Biological Corp. | JJX |
| Jan 27, 1994 | K935362 | P-AMYLASE CONTROL Beckman | JJX |
| Dec 29, 1993 | K934923 | CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET Unipath , Ltd., GB | JJX |
| Dec 29, 1993 | K934922 | CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET Unipath , Ltd., GB | JJX |
| Dec 2, 1993 | K932479 | B-HCG HUMAN SERUM CONTROLS Pyramid Biological Corp. | JJX |
| Nov 26, 1993 | K934521 | SPQ MALB CONTROL LEVEL II Incstar Corp. | JJX |
| Oct 28, 1993 | K932660 | LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2 More Diagnostics | JJX |
| Sep 24, 1993 | K933744 | SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES Sa Scientific, Inc. | JJX |
| Sep 21, 1993 | K932178 | AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES Tosoh Medics, Inc. | JJX |
| Aug 16, 1993 | K930007 | IMMULITE TSH THIRD GENERATION CONTROL Diagnostic Products Corp. | JJX |
| Aug 2, 1993 | K932870 | DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET Casco Standards | JJX |
| Jul 28, 1993 | K932659 | MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM More Diagnostics | JJX |
| Jul 28, 1993 | K932658 | CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3 More Diagnostics | JJX |
| Jun 29, 1993 | K932113 | CANNABINOID URINE CONTROLS Diagnostic Reagents, Inc. | JJX |
| Jun 22, 1993 | K931761 | QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI) Quidel Corp. | JJX |
| May 14, 1993 | K924859 | AIA-PACK IGE CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. | JJX |
| Apr 22, 1993 | K930874 | LD-1 CONTROL-LEVEL 1 & 2 Cala Diagnostics | JJX |
| Mar 22, 1993 | K925783 | AUTOSTAT ANTI-DSDNA Cogent Diagnotics , Ltd., GB | JJX |
| Mar 4, 1993 | K924860 | AIA-PACK AFP CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. | JJX |
| Feb 18, 1993 | K925906 | NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL Analytical Control Systems, Inc. | JJX |
| Feb 17, 1993 | K922754 | TANDEM-E IGE II CALIBRATION VERIFICATION SET Hybritech, Inc. | JJX |
| Feb 5, 1993 | K925880 | KODAK AMERLITE CK-MB CONTROL SERA LAN.4413 Eastman Kodak Company | JJX |
| Jan 28, 1993 | K925479 | SUGAR CHEX LINEARITY FOR THE ONE TOUCH Streck Laboratories, Inc. | JJX |
| Jan 26, 1993 | K926095 | REFRACTROL-SP Medical Specialties, 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 |
| Jan 11, 1993 | K924493 | DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD Casco Standards | JJX |
| Dec 28, 1992 | K926015 | CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 Cala Diagnostics | 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 |
| Nov 18, 1992 | K924675 | TSH - THIRD GENERATION LOW CONTROLS Nichols Institute | JJX |
| 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 |
| Nov 5, 1992 | K923821 | DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET Casco Standards | JJX |
| Nov 5, 1992 | K923794 | DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET Casco Standards | JJX |
| Nov 5, 1992 | K923793 | DOCUMENT CHEM III CALIBRATION VERIFICATION TEST Casco Standards | JJX |
| Aug 12, 1992 | K922995 | LIPID CONTROLS Creative Laboratory Products, Inc. | JJX |
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