SIMPLIFY D-DIMER, MODEL DCGK1— 510(k) K993276

Name: FDA 510(k) clearance K993276
Creator: U.S. Food and Drug Administration
Published: 1999-12-14

Substantially Equivalent

Agen Biomedical , Ltd.

FDA 510(k) clearance K993276 for SIMPLIFY D-DIMER, MODEL DCGK1, Substantially Equivalent on 1999-12-14. Applicant: Agen Biomedical , Ltd.. Device class: 2.

Clearance details

Applicant: Agen Biomedical , Ltd.
Product code: Code GHH
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1999-09-30
Decision date: 1999-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane, Queensland, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code GHH

view all

K112120 — DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET2013-01-24
K072288 — PATHFAST D-DIMER2009-05-06
K070453 — OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL2007-06-11
K062203 — TINA-QUANT D-DIMER TEST SYSTEM2007-03-14
K042890 — TRIAGE D-DIMER TEST, MODEL 981002004-11-29

More clearances from Agen Biomedical , Ltd.

view all

K974596 — DIMERTEST LATEX ASSAY1998-05-26
K945642 — AGEN DIMERTEST GOLD EIA1995-10-25
K905643 — BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY1991-04-12
K890189 — AGEN DIMERTEST EIA1989-03-03
K882944 — DIMERTEST(R) LATEX1988-08-17

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