AGGLUTINATING SERUM W135— 510(k) K771562

Name: FDA 510(k) clearance K771562
Creator: U.S. Food and Drug Administration
Published: 1977-08-25

Substantially Equivalent

Burroughs Wellcome Co.

FDA 510(k) clearance K771562 for AGGLUTINATING SERUM W135, Substantially Equivalent on 1977-08-25. Applicant: Burroughs Wellcome Co.. Device class: 2.

Clearance details

Applicant: Burroughs Wellcome Co.
Product code: Code GTJ
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1977-08-15
Decision date: 1977-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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