ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM— 510(k) K791386

Name: FDA 510(k) clearance K791386
Creator: U.S. Food and Drug Administration
Published: 1979-08-16

Substantially Equivalent

Immuno-Mycologics, Inc.

FDA 510(k) clearance K791386 for ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM, Substantially Equivalent on 1979-08-16. Applicant: Immuno-Mycologics, Inc.. Device class: 1.

Clearance details

Applicant: Immuno-Mycologics, Inc.
Product code: Code KFG
Device class: Class 1
Regulation: 21 CFR 866.3040
Advisory panel: Microbiology
Date received: 1979-07-11
Decision date: 1979-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KFG

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K904499 — NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)1991-07-01
K792686 — ASPERGILLUS SP, ANTISERUM POSITIVE1980-01-17
K792698 — ASPERGILLUS SP, ANTISERUM, POSITIVE1980-01-17
K760835 — ANTI-ASPERGILLUS CONT. SER. (MYCELIAL)1976-11-01

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