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 11, 1988 | K882736 | AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA Amersham Corp. | JJY |
| Oct 6, 1988 | K883147 | TRACE ELEMENTS SERUM TOXICOLOGY CONTROL Utak Laboratories, Inc. | JJY |
| Oct 6, 1988 | K882728 | AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190 Amersham Corp. | JJY |
| Sep 30, 1988 | K883124 | AMERLITE FREE THYROID CONTROL SERA LAN.4002 Amersham Corp. | JJY |
| Sep 13, 1988 | K883247 | LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL Quantimetrix Medical Industries | JJY |
| Sep 9, 1988 | K883012 | A.QC CHEMISTRY CONTROL LEVEL 2 Arden Medical Systems, Inc. | JJY |
| Aug 8, 1988 | K882727 | AMERLITE TOTAL THYROID CONTROL SERA LAN.4001 Amersham Corp. | JJY |
| Jul 21, 1988 | K882542 | LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II Bio-Rad | JJY |
| Jul 8, 1988 | K881503 | MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL Baxter Healthcare Corp | JJY |
| Jul 6, 1988 | K881438 | UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN Hichem Diagnostics | JJY |
| Jul 6, 1988 | K881437 | CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS Hichem Diagnostics | JJY |
| Jul 1, 1988 | K881113 | CLP LIPOPROTEIN ELECTROPHORESIS CONTROL Creative Laboratory Products, Inc. | JJY |
| Jun 2, 1988 | K881436 | SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS Hichem Diagnostics | JJY |
| May 27, 1988 | K881229 | AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693 Em Diagnostic Systems, Inc. | JJY |
| May 27, 1988 | K880447 | MULTI-FUNCTION BLOOD GAS CONTROL Bionostics, Inc. | JJY |
| May 16, 1988 | K881275 | URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II Fisher Scientific Co., LLC | JJY |
| Mar 3, 1988 | K880494 | LYPHOCHEK SPINAL FLUID CONTROL (HUMAN) Bio-Rad | JJY |
| Mar 1, 1988 | K880175 | DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL Baxter Healthcare Corp | JJY |
| Feb 18, 1988 | K874731 | LYPHOCHEK WHOLE BLOOD CONTROL Bio-Rad | JJY |
| Jan 21, 1988 | K874280 | LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II Bio-Rad | JJY |
| Jan 7, 1988 | K874809 | REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM Biotrol, USA, Inc. | JJY |
| Jan 5, 1988 | K874810 | REFERENCE ASSAYED CHEMISTRY CONTROL SERUM Biotrol, USA, Inc. | JJY |
| Jan 5, 1988 | K874772 | DC-TROL LEVEL 1 OR 2 Diagnostic Chemicals, Ltd. (Usa) | JJY |
| Dec 29, 1987 | K874459 | LIQUI-SERA SPINAL FLUID CONTROL Biodiagnostic Intl | JJY |
| Nov 23, 1987 | K874230 | PRECINORM L Boehringer Mannheim Corp. | JJY |
| Oct 20, 1987 | K873611 | A-QC CLINICAL CHEMISTRY CONTROL Arden Medical Systems, Inc. | JJY |
| Aug 26, 1987 | K872785 | BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM Biotrol, USA, Inc. | JJY |
| Aug 26, 1987 | K872777 | BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL Biotrol, USA, Inc. | JJY |
| Aug 5, 1987 | K872376 | LIPID CONTROL SERUM Biological Industries, IL | JJY |
| Jul 9, 1987 | K871977 | DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR American Dade | JJY |
| Jul 7, 1987 | K872304 | UNASSAYED CONTROL SERUM, NORMAL (BOVINE) Vanguard Diagnostic Systems | JJY |
| Jul 7, 1987 | K872303 | UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE) Vanguard Diagnostic Systems | JJY |
| Jul 6, 1987 | K872227 | LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II Bio-Rad | JJY |
| May 21, 1987 | K871342 | QM2/QM300 CONTROL A PACK Kallestad Diag, A Div. of Erbamont, Inc. | JJY |
| May 6, 1987 | K871537 | CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II Canyon Diagnostics, Inc. | JJY |
| Apr 6, 1987 | K871058 | SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) Fisher Scientific Co., LLC | JJY |
| Apr 6, 1987 | K870684 | LIQUID CHEMISTRY CONTROL, LEVEL I U. S. Diagnostics, Inc. | JJY |
| Apr 6, 1987 | K870683 | LIQUID CHEMISTRY CONTROL, LEVEL II U. S. Diagnostics, Inc. | JJY |
| Feb 20, 1987 | K870252 | DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET Casco Standards | JJY |
| Jan 13, 1987 | K862565 | CHEMTROL(TM) G.B.F. Industries, Inc. | JJY |
| Jan 9, 1987 | K861202 | TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS Nms Pharmaceuticals, Inc. | JJY |
| Nov 24, 1986 | K863849 | LIQUI-SERA COMBO LIGAND/TDM CONTROLS Biodiagnostic Intl | JJY |
| Nov 24, 1986 | K863751 | MULTI-ANALYTE LIN-TROL Sigma Diagnostics, Inc. | JJY |
| Oct 29, 1986 | K863648 | SERACON CT REFERENCE Bhp Diagnostix, Inc. | JJY |
| Oct 7, 1986 | K863745 | ABNORMAL SPINAL FLUID CONTROL Ciba Corning Diagnostics Corp. | JJY |
| Sep 16, 1986 | K861420 | QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL Quantimetrix Corp. | JJY |
| Sep 15, 1986 | K862963 | THERAPEUTIC DRUG MONITORING CONTROL SET American Monitor Corp. | JJY |
| Aug 4, 1986 | K862587 | CHEMTROL(TM) G.B.F. Industries, Inc. | JJY |
| Aug 4, 1986 | K862586 | CHEMVARION(TM) G.B.F. Industries, Inc. | JJY |
| Aug 4, 1986 | K862420 | UTAK-STABBS TOXICOLOGY CONTROL Utak Laboratories, Inc. | JJY |
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