FDA Product Code
FDA Product Code JIW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1150
510(k) Clearances — 17 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K973055 | WAKO CH50 LINEARITY SET | Wako Chemicals USA, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K970396 | HUMAN CHORIONIC GONADOTROPIN CALIBRATOR | Dade Chemistry Systems, Inc. | 1997-02-20 | Traditional | PDF ↗ |
| K910255 | FLOW CYTOMETRY FITC/PE COMPENSATION KIT | Sigma Diagnostics, Inc. | 1991-04-03 | Traditional | PDF ↗ |
| K902575 | SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) | Diagnostic Products Corp. | 1990-10-04 | Traditional | PDF ↗ |
| K902294 | ACCUSCAN MICROBEAD STANDARDS | Sigma Chemical Co. | 1990-07-03 | Traditional | PDF ↗ |
| K892213 | ACS COLLOID OSMOTIC PRESSURE CALIBRATOR | Analytical Control Systems, Inc. | 1989-06-21 | Traditional | PDF ↗ |
| K883389 | RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD | Reagents Applications, Inc. | 1988-12-14 | Traditional | PDF ↗ |
| K882220 | CALIBRATION KIT | King Diagnostics, Inc. | 1988-08-02 | Traditional | PDF ↗ |
| K880654 | AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 | American Research Products Co. | 1988-06-07 | Traditional | PDF ↗ |
| K880610 | UNIMETER CALIBRATION KIT | Boehringer Mannheim Corp. | 1988-03-24 | Traditional | PDF ↗ |
| K854028 | AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER | Verified Medical Research, Inc. | 1985-12-02 | Traditional | PDF ↗ |
| K851450 | FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM | Flow Cytometry Standards Corp. | 1985-09-16 | Traditional | PDF ↗ |
| K852260 | QUICK-CHEM CALIBRATION SET | Seragen Diagnostics, Inc. | 1985-07-22 | Traditional | PDF ↗ |
| K812220 | NEPHELOMETRIC SOLID TURBIDITY STANDARD | Hyland Therapeutic Div., Travenol Laboratories | 1981-08-18 | Traditional | PDF ↗ |
| K801300 | DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) | E.I. Dupont DE Nemours & Co., Inc. | 1980-07-08 | Traditional | PDF ↗ |
| K800304 | CENTRIFICHEM FILTER CALIBRATION SET | Union Carbide Corp. | 1980-03-12 | Traditional | PDF ↗ |
| K790643 | CENTRIFICHEM FILTER CALIBRATION SET | Union Carbide Corp. | 1979-05-23 | Traditional | PDF ↗ |
Product code JIW · Class II · Clinical Chemistry. Data: openFDA.