HEMA-SCREEN— 510(k) K902360

Substantially Equivalent

Immunostics Co., Inc.

FDA 510(k) clearance K902360 for HEMA-SCREEN, Substantially Equivalent on 1990-07-27. Applicant: Immunostics Co., Inc..

Clearance details

Applicant: Immunostics Co., Inc.
Product code: Code KHE
Advisory panel: Hematology
Date received: 1990-05-29
Decision date: 1990-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ocean, NJ, US

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