GOAT ANTI-RUBELLA ANTISERA— 510(k) K780010

Name: FDA 510(k) clearance K780010
Creator: U.S. Food and Drug Administration
Published: 1978-01-20

Substantially Equivalent

Northeast Biomedical Labs., Inc.

FDA 510(k) clearance K780010 for GOAT ANTI-RUBELLA ANTISERA, Substantially Equivalent on 1978-01-20. Applicant: Northeast Biomedical Labs., Inc.. Device class: 2.

Clearance details

Applicant: Northeast Biomedical Labs., Inc.
Product code: Code GOK
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1978-01-03
Decision date: 1978-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K780005 — GOAT ANTI-INFLUENZA ANTISERA1978-01-20
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