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 30, 1979 | K792024 | LIPOTROL Helena Laboratories | JJY |
| Oct 17, 1979 | K791958 | SERACON - EL DO27 Bhp Diagnostix, Inc. | JJY |
| Oct 1, 1979 | K791825 | LY-PRO-TROL #ACS-LP101 Analytical Control Systems, Inc. | JJY |
| Sep 24, 1979 | K791696 | CONTRO II Hi Chem, Inc. | JJY |
| Sep 24, 1979 | K791695 | CONTRO I Hi Chem, Inc. | JJY |
| Sep 17, 1979 | K791654 | NORMAL CONTROL Electrophoresis Corp. of America | JJY |
| Aug 16, 1979 | K791313 | ARS, CHEMISTRY Mid Tech, Inc. | JJY |
| Jul 30, 1979 | K791119 | MACOMB NORMAL CONTROL SERUM Macomb Chemical Co. | JJY |
| Jun 28, 1979 | K790840 | THYROID CONTROL SERA CODE QAS.101 Amersham Corp. | JJY |
| Apr 4, 1979 | K790371 | MACOMB LIPID CONTROL Macomb Chemical Co. | JJY |
| Mar 21, 1979 | K790264 | DATA-TOPE TRI-RAC RADIOASSAY CONTROL Dade, Baxter Travenol Diagnostics, Inc. | JJY |
| Mar 15, 1979 | K790330 | CALBIOCHEM-BEHRING LASER IMMUNOGLOBULIN Calbiochem-Behring Corp. | JJY |
| Feb 8, 1979 | K782038 | SERACON-C Bhp Diagnostix, Inc. | JJY |
| Dec 20, 1978 | K781893 | CONTROL, PROTEIN ELECTROPHORESIS Sigma Chemical Co. | JJY |
| Oct 17, 1978 | K781593 | RIA CONTROLS Dade, Baxter Travenol Diagnostics, Inc. | JJY |
| May 19, 1978 | K780552 | COMP. CLIN. CHEM. CONTROL SERUM-DECISION Beckman Instruments, Inc. | JJY |
| Apr 24, 1978 | K780351 | NORMAL UNASSAYED CONTROL SERA Macomb Chemical Co. | JJY |
| Mar 3, 1978 | K780096 | LDH ISOENZYME CONTROL SERUM Worthington Biochemical Corp. | JJY |
| Sep 2, 1977 | K771437 | SERONORM LIPID Nyegaard & Co. A/S | JJY |
| Apr 15, 1977 | K770380 | CHEMISTRY CONTROL-LOW & HIGH TQC TM Technicon Instruments Corp. | JJY |
| Apr 5, 1977 | K770312 | CHEMISTRY CONTROL, ABNORMAL Icn Pharmaceuticals, Inc. | JJY |
| Apr 5, 1977 | K770310 | CHEMISTRY CONTROL, NORMAL Icn Pharmaceuticals, Inc. | JJY |
| Nov 5, 1976 | K760818 | TRIS BICARBONATE DILUENT Hyland Therapeutic Div., Travenol Laboratories | JJY |
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