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. Device class: 2.

Clearance details

Applicant: Wellcome Diagnostics
Product code: Code DAP
Device class: Class 2
Regulation: 21 CFR 864.7320
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

Download summary PDF View on FDA.gov ↗

Recent devices under product code DAP

K253985 — INNOVANCE® D-Dimer 2.0 (SMN 10873803)2026-08-11
K172903 — HemosIL D-Dimer HS 5002017-11-22
K162227 — STA® - Liatest® D-Di2016-12-10
K160885 — HemosIL D-Dimer HS2016-10-27
K151534 — HemosIL D-Dimer HS2015-07-06

More clearances from Wellcome Diagnostics

K910797 — STREPTEX ACID EXTRACTION KIT1991-03-29
K895461 — WELLCOLEX COLOUR SHIGELLA TEST ZC511990-01-11
K890146 — WELLCOLEX COLOUR SALMONELLA TEST ZL 501989-02-16
K875311 — WELLCOZYME HSV WZO21988-08-03
K861628 — WELLCOZYME ROTAVIRUS WZ011987-01-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.