QUANTECH TOTAL B-HCG ASSAY— 510(k) K990258

Substantially Equivalent

Quantech , Ltd.

FDA 510(k) clearance K990258 for QUANTECH TOTAL B-HCG ASSAY, Substantially Equivalent on 1999-12-21. Applicant: Quantech , Ltd.. Device class: 2.

Clearance details

Applicant: Quantech , Ltd.
Product code: Code NAL
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1999-01-27
Decision date: 1999-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, CA, US

Download summary PDF View on FDA.gov ↗

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