BTC URINE LCG ASSAY— 510(k) K831125

Substantially Equivalent

Btc Diagnostics, Inc.

FDA 510(k) clearance K831125 for BTC URINE LCG ASSAY, Substantially Equivalent on 1983-05-05. Applicant: Btc Diagnostics, Inc..

Clearance details

Applicant: Btc Diagnostics, Inc.
Product code: Code JHJ
Advisory panel: Clinical Chemistry
Date received: 1983-04-05
Decision date: 1983-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.