Atlas FDA

CIA

5 FDA 510(k) clearances · Product code

45 daysmedian time to decision
203 days90th percentile
5clearances measured

FDA profile

Official device name
Methylthymol Blue, Calcium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1145
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
CALCIUM REAGENT-METHYL THYMOL BLUE METHOD (K870369)Trace Scientific , Ltd.1987-08-19
CALCIOMETER (K863059)J. D. Assoc.1986-09-26
DSL 1600 (K822898)Diagnostic Systems Laboratories, Inc.1982-12-09
ELVI CALCIUM (K792396)Volu Sol Medical Industries1979-12-06
MULTISTAT III CALCIUM TEST (K771468)Instrumentation Laboratory CO1977-09-12

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