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 |
|---|---|---|---|
| Jun 15, 1993 | K931373 | ANALYZER: STAT PROFILE PLUS 10 ANALYZER Nova Biomedical Corp. | JJY |
| May 12, 1993 | K931139 | DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET Casco Standards | JJY |
| Mar 26, 1993 | K925326 | ELECTROPHORESIS CONTROL LEVEL 1 Seradyn, Inc. | JJY |
| Mar 9, 1993 | K924802 | CALIBRATION VERIFICATION KIT OR CVK Radiometer America, Inc. | JJY |
| Mar 1, 1993 | K925256 | QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL Quantimetrix Corp. | JJY |
| Feb 23, 1993 | K924061 | CANCER ANTIGEN CONTROL Polymedco, Inc. | JJY |
| Jan 5, 1993 | K926046 | DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III Baxter Diagnostics, Inc. | JJY |
| Dec 18, 1992 | K924915 | SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479 Helena Laboratories | JJY |
| Nov 5, 1992 | K923795 | DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET Casco Standards | JJY |
| Nov 2, 1992 | K921477 | I-STAT(TM) LEVELS 1,2,3 CONTROLS I-Stat Corp., CA | JJY |
| Oct 13, 1992 | K923633 | MULTIQUAL ASSAY PRODUCTS Ciba Corning Diagnostics Corp. | JJY |
| Oct 13, 1992 | K923632 | MULTIQUAL UNASSAYED PRODUCTS Ciba Corning Diagnostics Corp. | JJY |
| Sep 25, 1992 | K923740 | KODAK AMERLITE TOTAL THYROID CONTROL SERA Eastman Kodak Company | JJY |
| Sep 2, 1992 | K920291 | MONI-TROL-L AND MONI-TROL-XL Medical Analysis Systems, Inc. | JJY |
| Aug 10, 1992 | K923165 | AMERLITE FREE THYROID CONTROL SERA LAN.4002 Eastman Kodak Company | JJY |
| Jul 10, 1992 | K922046 | LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 Bio-Rad | JJY |
| Jul 7, 1992 | K920636 | DADE URINE CHEMISTRY CONTROL LEVELS I AND II Baxter Diagnostics, Inc. | JJY |
| Jun 19, 1992 | K920927 | KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024 Helena Laboratories | JJY |
| Jun 9, 1992 | K921286 | LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2 Bio-Rad | JJY |
| May 7, 1992 | K920926 | KEMTROL SERUM CONTROL-ABNORMAL Helena Laboratories | JJY |
| Apr 17, 1992 | K920940 | AMERLITE FREE THYROID CONTROL SERA LAN.4002 Eastman Kodak Company | JJY |
| Apr 7, 1992 | K920826 | HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL Eastman Kodak Company | JJY |
| Mar 23, 1992 | K920350 | CHEM-CHEM MULTI-ANALYTE (MODIFIED) Streck Laboratories, Inc. | JJY |
| Mar 18, 1992 | K914958 | RIATRAC PLUS Becton Dickinson Advanced Diagnostics | JJY |
| Mar 17, 1992 | K914204 | TRI-POINT LIQUIMMUNE LIGAND CONTROL LEVELS 1,2,3 Medical Analysis Systems, Inc. | JJY |
| Feb 6, 1992 | K914890 | N/T PROTEIN CONTROL UY Behring Diagnostics, Inc. | JJY |
| Jan 9, 1992 | K914255 | LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2 Bio-Rad | JJY |
| Dec 18, 1991 | K915191 | RAI-TROL ELEVATED LIPIDS CONTROL Reagents Applications, Inc. | JJY |
| Nov 22, 1991 | K914619 | CVM Ciba Corning Diagnostics Corp. | JJY |
| Sep 27, 1991 | K913133 | CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) Bionostics, Inc. | JJY |
| Sep 25, 1991 | K913224 | LIPID LINEARITY CONTROLS Creative Laboratory Products, Inc. | JJY |
| Sep 19, 1991 | K913687 | CHEM-CHEX Streck Laboratories, Inc. | JJY |
| Sep 6, 1991 | K912718 | ENZYME LINEARITY CONTROL Phoenix Diagnostics, Inc. | JJY |
| Aug 12, 1991 | K912455 | DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL Baxter Healthcare Corp | JJY |
| Jul 30, 1991 | K912725 | TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL Creative Laboratory Products, Inc. | JJY |
| Jul 17, 1991 | K912441 | LINEARITY TEST KITS Boehringer Mannheim Corp. | JJY |
| Jun 13, 1991 | K911984 | ANEMIA I, II Ciba Corning Diagnostics Corp. | JJY |
| Jun 10, 1991 | K911854 | DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL Baxter Healthcare Corp | JJY |
| May 22, 1991 | K911755 | CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE Bionostics, Inc. | JJY |
| May 15, 1991 | K911803 | HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED Hichem Diagnostics | JJY |
| May 10, 1991 | K910440 | DOCUMENT REFLECTANCE II LINEARITY TEST SET Casco Standards | JJY |
| May 1, 1991 | K911171 | ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III Analytical Control Systems, Inc. | JJY |
| May 1, 1991 | K911169 | ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I Analytical Control Systems, Inc. | JJY |
| Jan 23, 1991 | K904989 | CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II Creative Laboratory Products, Inc. | JJY |
| Dec 26, 1990 | K905389 | CHEM-CHEX LIPID Streck Laboratories, Inc. | JJY |
| Dec 18, 1990 | K904784 | CHOLESTECH L.D.X. LEVEL 1 CONTROL Cholestech Corp. | JJY |
| Dec 18, 1990 | K904781 | CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL Cholestrech Corp. | JJY |
| Dec 7, 1990 | K904872 | HDL CHOLESTEROL CONTROL Analytical Control Systems, Inc. | JJY |
| Dec 7, 1990 | K902740 | LDL-DIRECT CONTROLS Isolab, Inc. | JJY |
| Dec 6, 1990 | K904968 | QCLYTE PROTEIN BASED ISE CONTROL Baxter Healthcare Corp | JJY |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.