Atlas FDA

CIL

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Cresol Red Colorimetry, Carbon-Dioxide
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1160
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
SYSTEMATE CALCIUM TEST TECHNICON RA 1000 (K922953)Em Diagnostic Systems, Inc.1992-09-09
PANCREATIC A-AMYLASE EPS (K895880)Boehringer Mannheim Corp.1989-12-19
ENZYMATIC CO2 (K833724)American Monitor Corp.1983-12-29
CO2 CONTENT (K800111)American Monitor Corp.1980-02-13

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