Panels › Clinical Chemistry › Product code JJR · Class 1
Electrolyte Controls (Assayed And Unassayed)
Regulation 862.1660
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 JJR
| Company | 510(k)s | Recalls |
|---|---|---|
| Bionostics, Inc. | 2 | 0 |
| Phoenix Diagnostics, Inc. | 2 | 0 |
| Quantimetrix Corp. | 2 | 0 |
| Aalto Scientific, Ltd. | 1 | 0 |
| Avl Scientific Corp. | 1 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Biomedical Research & Development Laboratories, Inc. | 1 | 0 |
| Casco Standards | 1 | 0 |
| Ciba Corning Diagnostics Corp. | 1 | 0 |
| I-Stat Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 27, 1999 | K990971 | EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 Medica Corp. | JJR |
| May 13, 1996 | K960592 | ELECTROLYTE STANDARDS Phoenix Diagnostics, Inc. | JJR |
| Mar 1, 1996 | K955630 | RNA MEDICAL HEMAT CONTROL Bionostics, Inc. | JJR |
| May 2, 1995 | K951435 | AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL Aalto Scientific, Ltd. | JJR |
| Oct 4, 1994 | K943925 | SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING Quantimetrix Corp. | JJR |
| Dec 9, 1993 | K934641 | I-STAT CONTROL LEVELS 1,2,3 I-Stat Corp. | JJR |
| Jul 19, 1991 | K912513 | ELECTROLYTE CONTROL Verichem Laboratories, Inc. | JJR |
| Jun 6, 1990 | K902266 | ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) Phoenix Diagnostics, Inc. | JJR |
| Oct 30, 1989 | K894576 | CIBA CORNING CERTAIN LYTE Ciba Corning Diagnostics Corp. | JJR |
| Oct 4, 1989 | K895582 | QCLYTE PROTEIN-BASED ISE CONTROL Baxter Healthcare Corp | JJR |
| Jun 10, 1988 | K881773 | DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET Casco Standards | JJR |
| May 27, 1988 | K881655 | SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL Biomedical Research & Development Laboratories, Inc. | JJR |
| Mar 24, 1988 | K880710 | PROTEIN BASE ISE CONTROL Bionostics, Inc. | JJR |
| Sep 29, 1986 | K863333 | AVL ISE-TROL ELECTROLYTE CONTROL Avl Scientific Corp. | JJR |
| Apr 13, 1984 | K834505 | HUMAN SERUM ELECTROLYTE CONTROL-LIQUID Quantimetrix Corp. | JJR |
| Aug 10, 1983 | K831389 | STAT-TRAK LIQUID ELECTROLYTE CONTROL United Diagnostics, Inc. | JJR |
| Nov 13, 1979 | K792196 | 8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO Photovolt Corp. | JJR |
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