Product code JJR— Clinical Chemistry
8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO
- Classification name
- Electrolyte Controls (Assayed And Unassayed)
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Total cleared
- 17
- First cleared
- Most recent
Market context for product code JJR
FDA has cleared devices under product code JJR between 1979 and 1999, filed by 14 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1999
- 1996
- 1995
- 1994
- 1993
- 1991
- 1990
- 1989
- 1988
- 1986
- 1984
- 1983
- 1979
Top applicants under product code JJR
Recent clearances under product code JJR
- K990971 — EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816
- K960592 — ELECTROLYTE STANDARDS
- K955630 — RNA MEDICAL HEMAT CONTROL
- K951435 — AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL
- K943925 — SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING
- K934641 — I-STAT CONTROL LEVELS 1,2,3
- K912513 — ELECTROLYTE CONTROL
- K902266 — ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)
- K894576 — CIBA CORNING CERTAIN LYTE
- K895582 — QCLYTE PROTEIN-BASED ISE CONTROL
- K881773 — DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET
- K881655 — SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL
- K880710 — PROTEIN BASE ISE CONTROL
- K863333 — AVL ISE-TROL ELECTROLYTE CONTROL
- K834505 — HUMAN SERUM ELECTROLYTE CONTROL-LIQUID
- K831389 — STAT-TRAK LIQUID ELECTROLYTE CONTROL
- K792196 — 8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO
Data sourced from openFDA. This site is unofficial and independent of the FDA.