Panels › Clinical Chemistry › Product code JIW · Class 2
Calibrator, Surrogate
Regulation 862.1150
0510(k)s in 12 months (17 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in JIW
| Company | 510(k)s | Recalls |
|---|---|---|
| Union Carbide Corp. | 2 | 0 |
| American Research Products Co. | 1 | 0 |
| Analytical Control Systems, Inc. | 1 | 0 |
| Boehringer Mannheim Corp. | 1 | 0 |
| Dade Chemistry Systems, Inc. | 1 | 0 |
| Diagnostic Products Corp. | 1 | 0 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 0 |
| Flow Cytometry Standards Corp. | 1 | 0 |
| Hyland Therapeutic Div., Travenol Laboratories | 1 | 0 |
| King Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 1997 | K973055 | WAKO CH50 LINEARITY SET Wako Chemicals USA, Inc. | JIW |
| Feb 20, 1997 | K970396 | HUMAN CHORIONIC GONADOTROPIN CALIBRATOR Dade Chemistry Systems, Inc. | JIW |
| Apr 3, 1991 | K910255 | FLOW CYTOMETRY FITC/PE COMPENSATION KIT Sigma Diagnostics, Inc. | JIW |
| Oct 4, 1990 | K902575 | SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) Diagnostic Products Corp. | JIW |
| Jul 3, 1990 | K902294 | ACCUSCAN MICROBEAD STANDARDS Sigma Chemical Co. | JIW |
| Jun 21, 1989 | K892213 | ACS COLLOID OSMOTIC PRESSURE CALIBRATOR Analytical Control Systems, Inc. | JIW |
| Dec 14, 1988 | K883389 | RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD Reagents Applications, Inc. | JIW |
| Aug 2, 1988 | K882220 | CALIBRATION KIT King Diagnostics, Inc. | JIW |
| Jun 7, 1988 | K880654 | AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 American Research Products Co. | JIW |
| Mar 24, 1988 | K880610 | UNIMETER CALIBRATION KIT Boehringer Mannheim Corp. | JIW |
| Dec 2, 1985 | K854028 | AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER Verified Medical Research, Inc. | JIW |
| Sep 16, 1985 | K851450 | FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM Flow Cytometry Standards Corp. | JIW |
| Jul 22, 1985 | K852260 | QUICK-CHEM CALIBRATION SET Seragen Diagnostics, Inc. | JIW |
| Aug 18, 1981 | K812220 | NEPHELOMETRIC SOLID TURBIDITY STANDARD Hyland Therapeutic Div., Travenol Laboratories | JIW |
| Jul 8, 1980 | K801300 | DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) E.I. Dupont DE Nemours & Co., Inc. | JIW |
| Mar 12, 1980 | K800304 | CENTRIFICHEM FILTER CALIBRATION SET Union Carbide Corp. | JIW |
| May 23, 1979 | K790643 | CENTRIFICHEM FILTER CALIBRATION SET Union Carbide Corp. | JIW |
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