GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY— 510(k) K983399

Substantially Equivalent

Genzyme Diagnostics

FDA 510(k) clearance K983399 for GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY, Substantially Equivalent on 1999-01-11. Applicant: Genzyme Diagnostics.

Clearance details

Applicant: Genzyme Diagnostics
Product code: Code MHI
Advisory panel: Microbiology
Date received: 1998-09-28
Decision date: 1999-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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