RABBIT KIDNEY CULTURE CELLS (FIRST PASS)— 510(k) K871033

Name: FDA 510(k) clearance K871033
Creator: U.S. Food and Drug Administration
Published: 1987-03-31

Substantially Equivalent

Microscan Div. Baxter Healthcare Corp.

FDA 510(k) clearance K871033 for RABBIT KIDNEY CULTURE CELLS (FIRST PASS), Substantially Equivalent on 1987-03-31. Applicant: Microscan Div. Baxter Healthcare Corp.. Device class: 1.

Clearance details

Applicant: Microscan Div. Baxter Healthcare Corp.
Product code: Code KIR
Device class: Class 1
Regulation: 21 CFR 864.2280
Advisory panel: Hematology
Date received: 1987-03-16
Decision date: 1987-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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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
K871231 — ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B1987-06-26
K871232 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 31987-06-26

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