AGEN DIMERTEST GOLD EIA— 510(k) K945642

Substantially Equivalent

Agen Biomedical , Ltd.

FDA 510(k) clearance K945642 for AGEN DIMERTEST GOLD EIA, Substantially Equivalent on 1995-10-25. 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: 1994-11-16
Decision date: 1995-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane, AU

Download summary PDF View on FDA.gov ↗

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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.