Panels › Clinical Chemistry › Product code JJY · Class 1
Multi-Analyte Controls, All Kinds (Assayed)
Regulation 862.1660
0510(k)s in 12 months (673 all time)
2recalls in 12 months (95 all time)
73recalls that name a 510(k)
Top companies in JJY
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio-Rad | 61 | 0 |
| Randox Laboratories Limited | 15 | 31 |
| Medical Analysis Systems, Inc. | 31 | 0 |
| Bio-Rad Laboratories | 26 | 1 |
| Roche Diagnostics | 22 | 4 |
| Cliniqa Corporation | 22 | 0 |
| Aalto Scientific, Ltd. | 19 | 0 |
| Maine Standards Co. | 19 | 0 |
| Boehringer Mannheim Corp. | 17 | 0 |
| Casco Standards | 15 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 1995 | K954074 | AALTO SCIENTIFIC LIQUID CARDIAC CONTROL Aalto Scientific, Ltd. | JJY |
| Sep 25, 1995 | K952385 | HEMA-TROL Q-CHECK Medical Specialties Intl., Inc. | JJY |
| Aug 24, 1995 | K952877 | CSF LIQUID CEREBROSPINAL FLUID CONTROL Medical Analysis Systems, Inc. | JJY |
| Jul 12, 1995 | K942647 | COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI Scantibodies Laboratory, Inc. | JJY |
| Jun 1, 1995 | K950802 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM International Enzymes, Inc. | JJY |
| May 23, 1995 | K943394 | PROSTAT CONTROL Quantimetrix Corp. | JJY |
| May 16, 1995 | K945651 | LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3 Bio-Rad | JJY |
| May 15, 1995 | K951749 | BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 Biocell Laboratories, Inc. | JJY |
| Apr 20, 1995 | K951170 | VIGIL MULTICHEK CONTROLS Beckman Instruments, Inc. | JJY |
| Apr 11, 1995 | K950469 | DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET Casco Standards | JJY |
| Mar 23, 1995 | K944728 | BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN ELECTROPHORESIS CONTROL Bioresource Technology, Inc. | JJY |
| Mar 21, 1995 | K944525 | LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3 Medical Analysis Systems, Inc. | JJY |
| Mar 20, 1995 | K950326 | KENLOR HUMAN SPINAL FLUID CONTROL Kenlor Industries, Inc. | JJY |
| Mar 13, 1995 | K942458 | PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED Randox Laboratories, Ltd., IE | JJY |
| Feb 22, 1995 | K950399 | RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL Bionostics, Inc. | JJY |
| Feb 10, 1995 | K946049 | LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2 Clinical Controls, Inc. | JJY |
| Jan 17, 1995 | K944455 | QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE) Beckman Instruments, Inc. | JJY |
| Jan 17, 1995 | K944454 | QUANITITATE GBCC VERIFIER SET Beckman Instruments, Inc. | JJY |
| Dec 29, 1994 | K943729 | DYE CHECK STRIPS 545-630 Awareness Technology, Inc. | JJY |
| Dec 9, 1994 | K945315 | DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL Casco Standards | JJY |
| Dec 2, 1994 | K944513 | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E International Enzymes, Inc. | JJY |
| Dec 2, 1994 | K944486 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E International Enzymes, Inc. | JJY |
| Dec 2, 1994 | K944452 | QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE) Beckman Instruments, Inc. | JJY |
| Nov 15, 1994 | K944059 | PROCHEQ 1 & 2 Prisma Systems | JJY |
| Oct 31, 1994 | K935599 | HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3 Clinical Controls, Inc. | JJY |
| Oct 7, 1994 | K942295 | VIROTROL TORCH Blackhawk Biosystems, Inc. | JJY |
| Oct 4, 1994 | K936245 | MULTI ANALYTE LINEARITY SET Teco Diagnostics | JJY |
| Sep 14, 1994 | K943754 | BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT Bionostics, Inc. | JJY |
| Sep 14, 1994 | K943290 | BILIRUBIN PLUS/PEDIATRIC CONTROLS Medi-Tech, Inc. | JJY |
| Aug 18, 1994 | K941328 | TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2 Medical Analysis Systems, Inc. | JJY |
| Jul 28, 1994 | K941876 | WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2 More Diagnostics | JJY |
| Jul 28, 1994 | K941698 | SERUM VOLATILES CONTROL - LEVELS 1 AND 2 More Diagnostics | JJY |
| Jul 20, 1994 | K941115 | ACS CARDIO-TROL CONTROL Analytical Control Systems, Inc. | JJY |
| Jun 16, 1994 | K941912 | N/T PROTEIN CONTROL SY/L, M, AND H Behring Diagnostics, Inc. | JJY |
| Apr 15, 1994 | K936184 | VIGIL PRX CHEMISTRY CONTROL Beckman-Diagnostic Systems Group | JJY |
| Apr 4, 1994 | K930534 | TMC I, II Ciba Corning Diagnostics Corp. | JJY |
| Mar 22, 1994 | K935219 | FERTILITY PLUS 1, 2, 3 Ciba Corning Diagnostics Corp. | JJY |
| Mar 11, 1994 | K940397 | ACS O DILVENT PROTEIN DILUTION MATRIX Analytical Control Systems, Inc. | JJY |
| Dec 27, 1993 | K933844 | PARA 4 PLUS Streck Laboratories, Inc. | JJY |
| Oct 28, 1993 | K933437 | DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3 Baxter Diagnostics, Inc. | JJY |
| Oct 21, 1993 | K934357 | LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2 Bio-Rad | JJY |
| Oct 18, 1993 | K934056 | TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3 Medical Analysis Systems, Inc. | JJY |
| Sep 24, 1993 | K933435 | DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2 Baxter Diagnostics, Inc. | JJY |
| Sep 1, 1993 | K930850 | BECKMAN VIGIL PLUS CONTROL Beckman Instruments, Inc. | JJY |
| Aug 11, 1993 | K933317 | LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 Bio-Rad | JJY |
| Aug 5, 1993 | K924919 | DADE(R) TUMOR MARKER CONTROL Baxter Diagnostics, Inc. | JJY |
| Jul 28, 1993 | K931366 | TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3 Medical Analysis Systems, Inc. | JJY |
| Jun 29, 1993 | K932458 | DOCUMENT ENZYME Casco Standards | JJY |
| Jun 29, 1993 | K932076 | LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II Bio-Rad | JJY |
| Jun 28, 1993 | K923663 | MULTITROL IMMUNOLOGY CONTROL Behring Diagnostics, Inc. | JJY |
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