I-ESTRIOL TEST SET— 510(k) K781599

Substantially Equivalent

Wien Laboratories, Inc.

FDA 510(k) clearance K781599 for I-ESTRIOL TEST SET, Substantially Equivalent on 1978-10-17. Applicant: Wien Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Wien Laboratories, Inc.
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1978-09-18
Decision date: 1978-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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