IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT— 510(k) K864998

Name: FDA 510(k) clearance K864998
Creator: U.S. Food and Drug Administration
Published: 1987-04-20

Substantially Equivalent

Boots-Celltech Diagnostics, Inc.

FDA 510(k) clearance K864998 for IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT, Substantially Equivalent on 1987-04-20. Applicant: Boots-Celltech Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Boots-Celltech Diagnostics, Inc.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 1986-12-22
Decision date: 1987-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkshire, England, GB

Download summary PDF View on FDA.gov ↗

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