RIA KIT, GAMMACOAT— 510(k) K782109

Substantially Equivalent

Clinical Assays, Inc.

FDA 510(k) clearance K782109 for RIA KIT, GAMMACOAT, Substantially Equivalent on 1979-01-26. Applicant: Clinical Assays, Inc.. Device class: 2.

Clearance details

Applicant: Clinical Assays, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1978-12-19
Decision date: 1979-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDX

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K943416 — DELFIA NEONATAL THYROXINE KIT1995-03-10
K934384 — AXSYM(TM) TOTAL T41994-06-21
K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-1161993-10-18

More clearances from Clinical Assays, Inc.

K832710 — VITAMIN B12 RADIOASSAY KIT CA-15341983-10-04
K832711 — VITAMIN B12 FOLATE CA-1515-1251983-10-04
K832712 — FOLATE RADIOASSAY KIT CA-1562-1251983-10-04
K823476 — GAMMADAB LH RADIO-KIT #CA-15081982-12-28
K823313 — IN VITRO GAMMACOAT B-HCG RADIO. TEST1982-12-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.