STANBIO SYPHILIS RPR TEST, NO. 1170— 510(k) K880144

Name: FDA 510(k) clearance K880144
Creator: U.S. Food and Drug Administration
Published: 1988-05-23

Substantially Equivalent

Stanbio Laboratory

FDA 510(k) clearance K880144 for STANBIO SYPHILIS RPR TEST, NO. 1170, Substantially Equivalent on 1988-05-23. Applicant: Stanbio Laboratory. Device class: 2.

Clearance details

Applicant: Stanbio Laboratory
Product code: Code GMQ
Device class: Class 2
Regulation: 21 CFR 866.3820
Advisory panel: Microbiology
Date received: 1988-01-13
Decision date: 1988-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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