PLATELET COUNTING KIT— 510(k) K802636

Name: FDA 510(k) clearance K802636
Creator: U.S. Food and Drug Administration
Published: 1980-12-11

Substantially Equivalent

Streck Laboratories, Inc.

FDA 510(k) clearance K802636 for PLATELET COUNTING KIT, Substantially Equivalent on 1980-12-11. Applicant: Streck Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Streck Laboratories, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1980-10-23
Decision date: 1980-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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