JJR — Electrolyte Controls (Assayed And Unassayed) Class I
FDA Device Classification
Classification Details
- Product Code
- JJR
- Device Class
- Class I
- Regulation Number
- 862.1660
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K990971 | medica | EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 | April 27, 1999 |
| K960592 | phoenix diagnostics | ELECTROLYTE STANDARDS | May 13, 1996 |
| K955630 | bionostics | RNA MEDICAL HEMAT CONTROL | March 1, 1996 |
| K951435 | aalto scientific | AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL | May 2, 1995 |
| K943925 | quantimetrix | SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING | October 4, 1994 |
| K934641 | i-stat | I-STAT CONTROL LEVELS 1,2,3 | December 9, 1993 |
| K912513 | verichem laboratories | ELECTROLYTE CONTROL | July 19, 1991 |
| K902266 | phoenix diagnostics | ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) | June 6, 1990 |
| K894576 | ciba corning diagnostics | CIBA CORNING CERTAIN LYTE | October 30, 1989 |
| K895582 | baxter healthcare | QCLYTE PROTEIN-BASED ISE CONTROL | October 4, 1989 |
| K881773 | casco standards | DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET | June 10, 1988 |
| K881655 | biomedical research and development laboratories | SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL | May 27, 1988 |
| K880710 | bionostics | PROTEIN BASE ISE CONTROL | March 24, 1988 |
| K863333 | avl scientific | AVL ISE-TROL ELECTROLYTE CONTROL | September 29, 1986 |
| K834505 | quantimetrix | HUMAN SERUM ELECTROLYTE CONTROL-LIQUID | April 13, 1984 |
| K831389 | united diagnostics | STAT-TRAK LIQUID ELECTROLYTE CONTROL | August 10, 1983 |
| K792196 | photovolt | 8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO | November 13, 1979 |