DeviceClearance

VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)— 510(k) K964720

Substantially Equivalent

Johnson & Johnson Clinical Diagnostics, Inc.

FDA 510(k) clearance K964720 for VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005), Substantially Equivalent on 1997-02-04. Applicant: Johnson & Johnson Clinical Diagnostics, Inc..

Clearance details

Applicant
Johnson & Johnson Clinical Diagnostics, Inc.
Product code
Code CGJ
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rochester, NY, US
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