EM-V— 510(k) K781397

Substantially Equivalent

Biological Corp. of America

FDA 510(k) clearance K781397 for EM-V, Substantially Equivalent on 1978-09-14. Applicant: Biological Corp. of America. Device class: 2.

Clearance details

Applicant: Biological Corp. of America
Product code: Code KSG
Device class: Class 2
Regulation: 21 CFR 864.9600
Advisory panel: Hematology
Date received: 1978-08-11
Decision date: 1978-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K800189 — BOVINE ALBUMIN 22% & 30% SOLUTIONS1980-02-13
K791791 — ORTHO ANTIBODY ENHANCEMENT SOLUTION1979-10-11

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