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 |
|---|---|---|---|
| Dec 6, 1990 | K904829 | ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL Analytical Control Systems, Inc. | JJY |
| Dec 6, 1990 | K904075 | CLINICAL CHEMISTRY CONTROL Phoenix Diagnostics, Inc. | JJY |
| Nov 9, 1990 | K904768 | KODATROL I AND II CONTROL AND DILUENT SET Eastman Kodak Company | JJY |
| Nov 1, 1990 | K904141 | TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III Medical Analysis Systems, Inc. | JJY |
| Oct 26, 1990 | K904099 | URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS Hichem Diagnostics | JJY |
| Oct 12, 1990 | K904293 | HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237) Hichem Diagnostics | JJY |
| Oct 4, 1990 | K903933 | DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2 Baxter Healthcare Corp | JJY |
| Sep 24, 1990 | K903566 | DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III Baxter Healthcare Corp | JJY |
| Sep 7, 1990 | K903407 | AFFINITY HLH TEST SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | JJY |
| Sep 7, 1990 | K903338 | KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL Kenlor Industries, Inc. | JJY |
| Sep 7, 1990 | K903310 | CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR Medical Analysis Systems, Inc. | JJY |
| Aug 22, 1990 | K902909 | CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROL Creative Laboratory Products, Inc. | JJY |
| Aug 17, 1990 | K903225 | CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT Medical Analysis Systems, Inc. | JJY |
| Aug 17, 1990 | K903190 | MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY Medical Analysis Systems, Inc. | JJY |
| Jul 19, 1990 | K902616 | BILIRUBIN CONTROL Phoenix Diagnostics, Inc. | JJY |
| Jul 19, 1990 | K902094 | BLOOD GAS/ISE CONTROLS Phoenix Diagnostics, Inc. | JJY |
| Jul 17, 1990 | K902673 | HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND Hi Chem, Inc. | JJY |
| Jul 17, 1990 | K902235 | LVM QUALITY CONTROL SERUM Ciba Corning Diagnostics Corp. | JJY |
| Jul 10, 1990 | K902573 | PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM Boehringer Mannheim Corp. | JJY |
| Jul 10, 1990 | K902536 | PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM Boehringer Mannheim Corp. | JJY |
| Jun 12, 1990 | K902095 | BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS Phoenix Diagnostics, Inc. | JJY |
| May 31, 1990 | K901988 | DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET Casco Standards | JJY |
| May 1, 1990 | K901212 | LIG/TDM A, B, C Ciba Corning Diagnostics Corp. | JJY |
| Apr 26, 1990 | K900717 | TECHNICON TESTPOINT(TM) LIGAND CONTROL Technicon Instruments Corp. | JJY |
| Apr 19, 1990 | K901115 | MULTICONSTITUENT SERUM RANGE LINEARITY #88234 Hichem Diagnostics | JJY |
| Apr 16, 1990 | K900993 | CHEM-CHEX Streck Laboratories, Inc. | JJY |
| Feb 2, 1990 | K892642 | DADE(R) TDM CONTROL Baxter Healthcare Corp | JJY |
| Jan 19, 1990 | K895862 | CLP NORMAL LIPID CONTROL Creative Laboratory Products, Inc. | JJY |
| Jan 18, 1990 | K895905 | LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3 Bio-Rad | JJY |
| Jan 10, 1990 | K896247 | CLP COMPREHENSIVE LIPID CONTROL-HR Creative Laboratory Products, Inc. | JJY |
| Jan 10, 1990 | K896246 | CLP COMPREHENSIVE LIPID CONTROL-LR Creative Laboratory Products, Inc. | JJY |
| Jan 2, 1990 | K896522 | DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY Casco Standards | JJY |
| Dec 27, 1989 | K895943 | NORMAL AND ABNORMAL CONTROL SERA Sclavo, Inc. | JJY |
| Sep 28, 1989 | K894852 | SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS Instrumentation Laboratory CO | JJY |
| Aug 11, 1989 | K894078 | LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II Bio-Rad | JJY |
| Aug 1, 1989 | K894252 | LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM Bio-Rad | JJY |
| Jul 20, 1989 | K893580 | DADE LIPID-TROL Baxter Healthcare Corp | JJY |
| Jun 23, 1989 | K893142 | DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET Casco Standards | JJY |
| Jun 23, 1989 | K893141 | DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET Casco Standards | JJY |
| Jun 13, 1989 | K891680 | LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II Bio-Rad | JJY |
| May 9, 1989 | K891929 | MONI-TROL(R) Baxter Healthcare Corp | JJY |
| Mar 20, 1989 | K890708 | AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE) Amersham Corp. | JJY |
| Mar 15, 1989 | K890470 | RIATRAC PLUS Bd Becton Dickinson Vacutainer Systems Preanalytic | JJY |
| Mar 15, 1989 | K890414 | RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109) Amersham Corp. | JJY |
| Mar 9, 1989 | K890576 | KENLOR HUMAN SPINAL FLUID CONTROL LIQUID Kenlor Industries, Inc. | JJY |
| Mar 8, 1989 | K890442 | SHAPE-ACTIO URINALYSIS CONTROLS Actio, Inc. | JJY |
| Jan 27, 1989 | K884977 | GAS TRAK PLUS United Diagnostics, Inc. | JJY |
| Nov 10, 1988 | K883942 | HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL Icl Scientific | JJY |
| Oct 25, 1988 | K882486 | LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II Bio-Rad | JJY |
| Oct 13, 1988 | K883861 | DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST Casco Standards | JJY |
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