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.. Device class: 2.

Clearance details

Applicant: Btc Diagnostics, Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
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 ↗

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More clearances from Btc Diagnostics, Inc.

K841545 — ENZYME IMMUNOASSAY FOR DETECTION HORM1984-11-27
K832905 — QUALITATIVE ENZYME IMMUNOASSAY-DETECT1984-02-03
K833710 — BTC URINE LH ASSAY1984-01-30
K831604 — HCG ACCU-STICK1983-07-19

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