Calibrator, Surrogate
FDA product code JIW · Class II (moderate risk) · 21 CFR 862.1150 · Clinical Chemistry
17510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Union Carbide Corp. 2
- E.I. Dupont DE Nemours & Co., Inc. 1
- Hyland Therapeutic Div., Travenol Laboratories 1
- Seragen Diagnostics, Inc. 1
- Flow Cytometry Standards Corp. 1
- Verified Medical Research, Inc. 1
- Boehringer Mannheim Corp. 1
- American Research Products Co. 1
- King Diagnostics, Inc. 1
- Reagents Applications, Inc. 1
- Analytical Control Systems, Inc. 1
- Sigma Chemical Co. 1
- Diagnostic Products Corp. 1
- Sigma Diagnostics, Inc. 1
- Dade Chemistry Systems, Inc. 1
- Wako Chemicals USA, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973055 | Wako CH50 Linearity SetJIW · Traditional | Wako Chemicals USA, Inc. | 09/25/1997SE |
| K970396 | Human Chorionic Gonadotropin CalibratorJIW · Traditional | Dade Chemistry Systems, Inc. | 02/20/1997SE |
| K910255 | Flow Cytometry Fitc/Pe Compensation KitJIW · Traditional | Sigma Diagnostics, Inc. | 04/03/1991SE |
| K902575 | Sopheia 1000 (S1CAL) & Sopheia 2000 (S2CAL)JIW · Traditional | Diagnostic Products Corp. | 10/04/1990SE |
| K902294 | Accuscan Microbead StandardsJIW · Traditional | Sigma Chemical Co. | 07/03/1990SE |
| K892213 | Acs Colloid Osmotic Pressure CalibratorJIW · Traditional | Analytical Control Systems, Inc. | 06/21/1989SE |
| K883389 | Raichem(Tm) Bilirubin Conjugate StandardJIW · Traditional | Reagents Applications, Inc. | 12/14/1988SE |
| K882220 | Calibration KitJIW · Traditional | King Diagnostics, Inc. | 08/02/1988SE |
| K880654 | Amresco Liquizyme Glucose/Bun Standard 0124, 0200JIW · Traditional | American Research Products Co. | 06/07/1988SE |
| K880610 | Unimeter Calibration KitJIW · Traditional | Boehringer Mannheim Corp. | 03/24/1988SE |
| K854028 | Audit Automated Blood Chemistry AnalyzerJIW · Traditional | Verified Medical Research, Inc. | 12/02/1985SE |
| K851450 | Fluorescent Microbead Alignment Standards TMJIW · Traditional | Flow Cytometry Standards Corp. | 09/16/1985SE |
| K852260 | Quick-Chem Calibration SetJIW · Traditional | Seragen Diagnostics, Inc. | 07/22/1985SE |
| K812220 | Nephelometric Solid Turbidity StandardJIW · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 08/18/1981SE |
| K801300 | Dupont 'Aca' Conjugated Bilirubin(Cbil)JIW · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 07/08/1980SE |
| K800304 | Centrifichem Filter Calibration SetJIW · Traditional | Union Carbide Corp. | 03/12/1980SE |
| K790643 | Centrifichem Filter Calibration SetJIW · Traditional | Union Carbide Corp. | 05/23/1979SE |