DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70— 510(k) K895965

Name: FDA 510(k) clearance K895965
Creator: U.S. Food and Drug Administration
Published: 1990-12-26

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K895965 for DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70, Substantially Equivalent on 1990-12-26. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code LIP
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1989-10-11
Decision date: 1990-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, CT, US

Download summary PDF View on FDA.gov ↗

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