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 |
|---|---|---|---|
| Feb 10, 1997 | K970148 | ELECSYS CALCHECK ESTRADIOL Boehringer Mannheim Corp. | JJX |
| Feb 6, 1997 | K970176 | HCG CONTROLS International Newtech Development, Inc., CA | JJX |
| Jan 30, 1997 | K970146 | ELECSYS CALCHECK TESTOSTERONE Boehringer Mannheim Corp. | JJX |
| Dec 16, 1996 | K964830 | ELECSYS CALCHECK LH Boehringer Mannheim Corp. | JJX |
| Nov 22, 1996 | K964278 | WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 Clinical Controls, Inc. | JJX |
| Nov 8, 1996 | K963909 | HEMOCUE GLUCOLIN Direct Solutions | JJX |
| Nov 1, 1996 | K964053 | HEMOCUE GLUCOTROL Direct Solutions | JJX |
| Oct 28, 1996 | K961432 | RADIAS GALT TEST Bio-Rad | JJX |
| Oct 7, 1996 | K963551 | BIO-CSF LIQUID CONTROL LEVEL 1 AND 2 Biocell Laboratories, Inc. | JJX |
| Sep 10, 1996 | K963181 | ELECSYS CALCHECK T UPDATE Boehringer Mannheim Corp. | JJX |
| Aug 30, 1996 | K963165 | ELECSYS CALCHECK HCG Boehringer Mannheim Corp. | JJX |
| Aug 29, 1996 | K963240 | IMMULITE ACTH CONTROL MODULE (LACCM) Diagnostic Products Corp. | JJX |
| Aug 29, 1996 | K962975 | PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) Diagnostic Products Corp. | JJX |
| Aug 27, 1996 | K963178 | ELECSYS CALCHECK T4 Boehringer Mannheim Corp. | JJX |
| Aug 27, 1996 | K963167 | ELECYS CALCHECK T 3 Boehringer Mannheim Corp. | JJX |
| Aug 27, 1996 | K963164 | ELECSYS CALCHECK FT4 Boehringer Mannheim Corp. | JJX |
| Aug 27, 1996 | K963163 | ELECSYS CALCHECK FT3 Boehringer Mannheim Corp. | JJX |
| Aug 23, 1996 | K963182 | ELECSYS CALCHECK CK-MB Boehringer Mannheim Corp. | JJX |
| Aug 23, 1996 | K963147 | ELECSYS CALCHECK TSH Boehringer Mannheim Corp. | JJX |
| Aug 23, 1996 | K963143 | ELECSYS CALCHECK TROPONIN T Boehringer Mannheim Corp. | JJX |
| Aug 20, 1996 | K963085 | LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III International Enzymes, Inc. | JJX |
| Aug 15, 1996 | K962841 | OPUS MYOGLOBIN CONTROLS Behring Diagnostics, Inc. | JJX |
| Jul 22, 1996 | K962694 | OPUS B12 CONTROLS Behring Diagnostics, Inc. | JJX |
| Jul 22, 1996 | K962573 | ELECSYS PRECICONTROL TSH Boehringer Mannheim Corp. | JJX |
| Jul 5, 1996 | K962432 | LIQUISPEX URINE (MICRO)ALBUMIN CONTROL Clinical Controls, Inc. | JJX |
| Jun 17, 1996 | K961510 | ACS FRT4 IMMUNOASSAY Ciba Corning Diagnostics Corp. | JJX |
| Jun 14, 1996 | K960874 | COMPLEMENT CONTROL Wako Chemicals USA, Inc. | JJX |
| Apr 23, 1996 | K961206 | OPUS T3 CONTROLS Behring Diagnostics, Inc. | JJX |
| Apr 3, 1996 | K960378 | ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS Actimed Laboratories, Inc. | JJX |
| Mar 20, 1996 | K955629 | LXN FRUCTOSAMINE TEST Lxn Corp. | JJX |
| Mar 13, 1996 | K960154 | PSA CONTROLS Diagnostic Products Corp. | JJX |
| Feb 29, 1996 | K955796 | IRON CALIBRATOR & CALIBRATION VERIFICATION SET Data Medical Associates, Inc. | JJX |
| Feb 23, 1996 | K955468 | OPUS PROLACTIN CONTROLS Behring Diagnostics, Inc. | JJX |
| Dec 6, 1995 | K955141 | OSOM HCG COMBO TEST Wyntek Diagnostics, Inc. | JJX |
| Nov 14, 1995 | K953883 | ACCESS LOW LEVEL IGE CONTROLS Bio-Rad Laboratories, Inc. | JJX |
| Oct 6, 1995 | K954144 | OPUS HCG CONTROLS Behring Diagnostics, Inc. | JJX |
| Sep 8, 1995 | K952251 | IMMULITE HCG HIGH LEVEL CONTROL MODULE Diagnostic Products Corp. | JJX |
| Aug 24, 1995 | K953097 | OPUS T4 CONTROLS Behring Diagnostics, Inc. | JJX |
| Jul 13, 1995 | K951888 | DADE STRATUS TROPONIN-I CONTROL Dade Intl., Inc. | JJX |
| Jun 6, 1995 | K944999 | SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 More Diagnostics | JJX |
| Apr 3, 1995 | K950072 | IMMULITE(R) TBG Diagnostic Products Corp. | JJX |
| Mar 30, 1995 | K950590 | REP CHOLESTEROL PROFILE CONTROL Helena Laboratories | JJX |
| Mar 20, 1995 | K950589 | CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL Creative Laboratory Products, Inc. | JJX |
| Feb 8, 1995 | K946144 | LIQUISPEX(TM) URINE ETHANOL CONTROL Clinical Controls, Inc. | JJX |
| Feb 3, 1995 | K946143 | CHEMSPEX(TM) AMMONIA CONTROL Clinical Controls, Inc. | JJX |
| Jan 17, 1995 | K945718 | DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET Casco Standards | JJX |
| Jan 17, 1995 | K944785 | SAS QUANT HCG SERUM Sa Scientific, Inc. | JJX |
| Nov 30, 1994 | K944361 | DOCUMENT R AMMONIA/ETHANOL CONTROL Casco Standards | JJX |
| Nov 22, 1994 | K944453 | QUANTITATE URIC ACID VERIFIER SET Beckman Instruments, Inc. | JJX |
| Nov 17, 1994 | K944891 | SAS QUANT HCG URINE Sa Scientific, Inc. | JJX |
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