DIMERTEST(R) LATEX— 510(k) K882944

Substantially Equivalent

Agen Biomedical , Ltd.

FDA 510(k) clearance K882944 for DIMERTEST(R) LATEX, Substantially Equivalent on 1988-08-17. Applicant: Agen Biomedical , Ltd.. Device class: 2.

Clearance details

Applicant: Agen Biomedical , Ltd.
Product code: Code DAP
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1988-07-14
Decision date: 1988-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane, AU

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 Agen Biomedical , Ltd.

K993276 — SIMPLIFY D-DIMER, MODEL DCGK11999-12-14
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

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