ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B— 510(k) K871231

Name: FDA 510(k) clearance K871231
Creator: U.S. Food and Drug Administration
Published: 1987-06-26

Substantially Equivalent

Microscan Div. Baxter Healthcare Corp.

FDA 510(k) clearance K871231 for ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B, Substantially Equivalent on 1987-06-26. Applicant: Microscan Div. Baxter Healthcare Corp.. Device class: 1.

Clearance details

Applicant: Microscan Div. Baxter Healthcare Corp.
Product code: Code GNX
Device class: Class 1
Regulation: 21 CFR 866.3330
Advisory panel: Microbiology
Date received: 1987-03-27
Decision date: 1987-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Microscan Div. Baxter Healthcare Corp.

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K871228 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 21987-06-26
K871229 — ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL1987-06-26
K871230 — ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS1987-06-26
K871232 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 31987-06-26
K871233 — ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A1987-06-26

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