IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST— 510(k) K921968

Name: FDA 510(k) clearance K921968
Creator: U.S. Food and Drug Administration
Published: 1996-06-28

Substantially Equivalent

Tech-Co, Inc.

FDA 510(k) clearance K921968 for IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST, Substantially Equivalent on 1996-06-28. Applicant: Tech-Co, Inc.. Device class: 2.

Clearance details

Applicant: Tech-Co, Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1992-04-27
Decision date: 1996-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Placentia, CA, US

Download summary PDF View on FDA.gov ↗

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