WHOLE BLOOD PLATELET CONTROL NORMAL,— 510(k) K792606

Name: FDA 510(k) clearance K792606
Creator: U.S. Food and Drug Administration
Published: 1980-02-13

Substantially Equivalent

Dade, Baxter Travenol Diagnostics, Inc.

FDA 510(k) clearance K792606 for WHOLE BLOOD PLATELET CONTROL NORMAL,, Substantially Equivalent on 1980-02-13. Applicant: Dade, Baxter Travenol Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Dade, Baxter Travenol Diagnostics, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1979-12-18
Decision date: 1980-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K792443 — TSH RADIOIMMUNOASSAY1979-12-27
K792442 — FERRITIN RADIOIMMUNOASSAY1979-12-18

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