CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)— 510(k) K873625

Name: FDA 510(k) clearance K873625
Creator: U.S. Food and Drug Administration
Published: 1987-10-20

Substantially Equivalent

Boots-Celltech Diagnostics, Inc.

FDA 510(k) clearance K873625 for CHEMELIA ENZYME IMMUNOASSAY FOR (TSH), Substantially Equivalent on 1987-10-20. Applicant: Boots-Celltech Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Boots-Celltech Diagnostics, Inc.
Product code: Code JLM
Device class: Class 2
Regulation: 21 CFR 864.7360
Advisory panel: Hematology
Date received: 1987-09-08
Decision date: 1987-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkshire, England, GB

Download summary PDF View on FDA.gov ↗

More clearances from Boots-Celltech Diagnostics, Inc.

view all

K871877 — IDEIA HERPES SIMPLEX VIRUS TEST1989-11-17
K880799 — MODIFIED IDEIA CHLAMYDIA TEST1988-12-08
K880758 — SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY1988-04-18
K874875 — CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)1988-03-24
K872958 — IMAGEN INFLUENZA VIRUS A AND B TESTMI1988-02-24

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