CELLABS GIARDIA CEL I.F. TEST— 510(k) K912152

Name: FDA 510(k) clearance K912152
Creator: U.S. Food and Drug Administration
Published: 1991-08-12

Substantially Equivalent

Celltech Diagnostics , Ltd.

FDA 510(k) clearance K912152 for CELLABS GIARDIA CEL I.F. TEST, Substantially Equivalent on 1991-08-12. Applicant: Celltech Diagnostics , Ltd.. Device class: 2.

Clearance details

Applicant: Celltech Diagnostics , Ltd.
Product code: Code MHI
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1991-05-15
Decision date: 1991-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suite 11oo, Washington, DC, US

Download summary PDF View on FDA.gov ↗

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