BTC URINE LH ASSAY— 510(k) K833710

Substantially Equivalent

Btc Diagnostics, Inc.

FDA 510(k) clearance K833710 for BTC URINE LH ASSAY, Substantially Equivalent on 1984-01-30. Applicant: Btc Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Btc Diagnostics, Inc.
Product code: Code CED
Device class: Class 1
Regulation: 21 CFR 862.1520
Advisory panel: Clinical Chemistry
Date received: 1983-10-20
Decision date: 1984-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CED

K894288 — PHOSPHORUS TEST ITEM NUMBER 654161989-08-31
K840151 — EKTACHEM CLINICAL CHEM. SLIDES1984-03-22
K820832 — PHOSPHORUS IL1982-04-15
K812670 — SANDARE FAST 340 PHOSPHORUS PROCEDURE1981-10-02
K811864 — SIGMA PROCEDURE 265-UV1981-07-31

More clearances from Btc Diagnostics, Inc.

K841545 — ENZYME IMMUNOASSAY FOR DETECTION HORM1984-11-27
K832905 — QUALITATIVE ENZYME IMMUNOASSAY-DETECT1984-02-03
K831604 — HCG ACCU-STICK1983-07-19
K831125 — BTC URINE LCG ASSAY1983-05-05

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