FDA Product Code
FDA Product Code JJR — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1660
510(k) Clearances — 17 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K990971 | EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 | Medica Corp. | 1999-04-27 | Traditional | PDF ↗ |
| K960592 | ELECTROLYTE STANDARDS | Phoenix Diagnostics, Inc. | 1996-05-13 | Traditional | PDF ↗ |
| K955630 | RNA MEDICAL HEMAT CONTROL | Bionostics, Inc. | 1996-03-01 | Traditional | PDF ↗ |
| K951435 | AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL | Aalto Scientific, Ltd. | 1995-05-02 | Traditional | PDF ↗ |
| K943925 | SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING | Quantimetrix Corp. | 1994-10-04 | Traditional | PDF ↗ |
| K934641 | I-STAT CONTROL LEVELS 1,2,3 | I-Stat Corp. | 1993-12-09 | Traditional | PDF ↗ |
| K912513 | ELECTROLYTE CONTROL | Verichem Laboratories, Inc. | 1991-07-19 | Traditional | PDF ↗ |
| K902266 | ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) | Phoenix Diagnostics, Inc. | 1990-06-06 | Traditional | PDF ↗ |
| K894576 | CIBA CORNING CERTAIN LYTE | Ciba Corning Diagnostics Corp. | 1989-10-30 | Traditional | PDF ↗ |
| K895582 | QCLYTE PROTEIN-BASED ISE CONTROL | Baxter Healthcare Corp | 1989-10-04 | Traditional | PDF ↗ |
| K881773 | DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET | Casco Standards | 1988-06-10 | Traditional | PDF ↗ |
| K881655 | SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL | Biomedical Research & Development Laboratories, Inc. | 1988-05-27 | Traditional | PDF ↗ |
| K880710 | PROTEIN BASE ISE CONTROL | Bionostics, Inc. | 1988-03-24 | Traditional | PDF ↗ |
| K863333 | AVL ISE-TROL ELECTROLYTE CONTROL | Avl Scientific Corp. | 1986-09-29 | Traditional | PDF ↗ |
| K834505 | HUMAN SERUM ELECTROLYTE CONTROL-LIQUID | Quantimetrix Corp. | 1984-04-13 | Traditional | PDF ↗ |
| K831389 | STAT-TRAK LIQUID ELECTROLYTE CONTROL | United Diagnostics, Inc. | 1983-08-10 | Traditional | PDF ↗ |
| K792196 | 8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO | Photovolt Corp. | 1979-11-13 | Traditional | PDF ↗ |
Product code JJR · Class I · Clinical Chemistry. Data: openFDA.