D-DIMER WELLCOTEST (HA10)— 510(k) K915203

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K915203 for D-DIMER WELLCOTEST (HA10), Substantially Equivalent on 1992-01-31. Applicant: Wellcome Diagnostics.

Clearance details

Applicant: Wellcome Diagnostics
Product code: Code DAP
Advisory panel: Hematology
Date received: 1991-11-18
Decision date: 1992-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Pk, NC, US

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