REAGENT, COCCI LATEX— 510(k) K782070

Substantially Equivalent

I M, Inc.

FDA 510(k) clearance K782070 for REAGENT, COCCI LATEX, Substantially Equivalent on 1979-02-01. Applicant: I M, Inc.. Device class: 2.

Clearance details

Applicant: I M, Inc.
Product code: Code GMG
Device class: Class 2
Regulation: 21 CFR 866.3135
Advisory panel: Microbiology
Date received: 1978-12-12
Decision date: 1979-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code GMG

K812189 — COCCIDIOIDES LATEX AGGLUTINATION1981-08-25
K792690 — COCCIDIOIDES IMMITIS, LATEX AGGLUTI1980-01-17
K791381 — COCCIDIODES (COCCI)1979-08-16
K760829 — COCCIDIOIDES MYCELIAL ANTIGEN1976-11-01

More clearances from I M, Inc.

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K880753 — UMBILICAL CORD CLAMP1988-04-27
K872741 — NUTRIPUMP1987-10-20

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