DETECTACULT— 510(k) K854619

Substantially Equivalent

Immunostics Co., Inc.

FDA 510(k) clearance K854619 for DETECTACULT, Substantially Equivalent on 1986-03-03. Applicant: Immunostics Co., Inc..

Clearance details

Applicant: Immunostics Co., Inc.
Product code: Code KHE
Advisory panel: Hematology
Date received: 1985-11-18
Decision date: 1986-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Metuchen, NJ, US

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