ALKALINE PHOSPHATASE, LEUKOCYTE, KIT— 510(k) K896092

Name: FDA 510(k) clearance K896092
Creator: U.S. Food and Drug Administration
Published: 1989-11-09

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K896092 for ALKALINE PHOSPHATASE, LEUKOCYTE, KIT, Substantially Equivalent on 1989-11-09. Applicant: Sigma Chemical Co.. Device class: 1.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code GHD
Device class: Class 1
Regulation: 21 CFR 864.7660
Advisory panel: Hematology
Date received: 1989-10-19
Decision date: 1989-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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