ANTI-HISTOPLASMA CONTROL SERUM (YEAST)— 510(k) K760832

Name: FDA 510(k) clearance K760832
Creator: U.S. Food and Drug Administration
Published: 1976-11-01

Substantially Equivalent

I M, Inc.

FDA 510(k) clearance K760832 for ANTI-HISTOPLASMA CONTROL SERUM (YEAST), Substantially Equivalent on 1976-11-01. Applicant: I M, Inc.. Device class: 2.

Clearance details

Applicant: I M, Inc.
Product code: Code GMK
Device class: Class 2
Regulation: 21 CFR 866.3320
Advisory panel: Microbiology
Date received: 1976-10-13
Decision date: 1976-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GMK

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K792679 — HISTOPLASMA CAPSULATUM, ANTISERUM1980-01-17
K792718 — HISTOPLASMA CAPSULATUM, ANTISERUM1980-01-17
K791390 — ANTI-BLASTOMYCES SERUM #CF10027X1979-08-16

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K872741 — NUTRIPUMP1987-10-20

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