OLYMPUS PK(TM) TP— 510(k) K893124

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K893124 for OLYMPUS PK(TM) TP, Substantially Equivalent on 1989-11-17. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code GMT
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1989-04-25
Decision date: 1989-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Caldwell, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GMT

K971502 — SERODIA TP-PA1997-11-13
K911640 — OLYMPUS PK TP(TM) SYSTEM, MODIFICATION1991-07-24
K911266 — MODIFIED PK TP CONTROL1991-05-07
K905038 — OLYMPUS PK-TP ABSORBENT KIT1991-05-06
K896410 — CELLOGNOST SYPHILIS H1990-05-15

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