ALKALINE PHOSPHATASE CAT. # 306-22, 306-23— 510(k) K875210

Name: FDA 510(k) clearance K875210
Creator: U.S. Food and Drug Administration
Published: 1988-02-02

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K875210 for ALKALINE PHOSPHATASE CAT. # 306-22, 306-23, Substantially Equivalent on 1988-02-02. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1987-12-18
Decision date: 1988-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroe, CT, US

Download summary PDF View on FDA.gov ↗

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