Atlas FDA

JJR

17 FDA 510(k) clearances · Product code

43 daysmedian time to decision
103 days90th percentile
17clearances measured

FDA profile

Official device name
Electrolyte Controls (Assayed And Unassayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
1992: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 (K990971)Medica Corp.1999-04-27
ELECTROLYTE STANDARDS (K960592)Phoenix Diagnostics, Inc.1996-05-13
RNA MEDICAL HEMAT CONTROL (K955630)Bionostics, Inc.1996-03-01
AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL (K951435)Aalto Scientific, Ltd.1995-05-02
SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING (K943925)Quantimetrix Corp.1994-10-04
I-STAT CONTROL LEVELS 1,2,3 (K934641)I-Stat Corp.1993-12-09
ELECTROLYTE CONTROL (K912513)Verichem Laboratories, Inc.1991-07-19
ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) (K902266)Phoenix Diagnostics, Inc.1990-06-06
CIBA CORNING CERTAIN LYTE (K894576)Ciba Corning Diagnostics Corp.1989-10-30
QCLYTE PROTEIN-BASED ISE CONTROL (K895582)Baxter Healthcare Corp1989-10-04
DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET (K881773)Casco Standards1988-06-10
SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL (K881655)Biomedical Research & Development Laboratories, Inc.1988-05-27
PROTEIN BASE ISE CONTROL (K880710)Bionostics, Inc.1988-03-24
AVL ISE-TROL ELECTROLYTE CONTROL (K863333)Avl Scientific Corp.1986-09-29
HUMAN SERUM ELECTROLYTE CONTROL-LIQUID (K834505)Quantimetrix Corp.1984-04-13
STAT-TRAK LIQUID ELECTROLYTE CONTROL (K831389)United Diagnostics, Inc.1983-08-10
8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO (K792196)Photovolt Corp.1979-11-13

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Every clearance here is in the API, with alerts when new ones post.