DIMERTEST LATEX ASSAY— 510(k) K974596

Substantially Equivalent

Agen Biomedical , Ltd.

FDA 510(k) clearance K974596 for DIMERTEST LATEX ASSAY, Substantially Equivalent on 1998-05-26. 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: 1997-12-09
Decision date: 1998-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane 4110, AU

Download summary PDF View on FDA.gov ↗

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More clearances from Agen Biomedical , Ltd.

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

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