SERODIA TP-PA— 510(k) K971502

Substantially Equivalent

Scimedx Tekfile Services

FDA 510(k) clearance K971502 for SERODIA TP-PA, Substantially Equivalent on 1997-11-13. Applicant: Scimedx Tekfile Services. Device class: 2.

Clearance details

Applicant: Scimedx Tekfile Services
Product code: Code GMT
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1997-04-24
Decision date: 1997-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denvill, NJ, US

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Recent devices under product code GMT

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
K893124 — OLYMPUS PK(TM) TP1989-11-17

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