TRANSTAT-CMV(TM)— 510(k) K903308

Substantially Equivalent

Ab Sangtec Medical

FDA 510(k) clearance K903308 for TRANSTAT-CMV(TM), Substantially Equivalent on 1990-12-04. Applicant: Ab Sangtec Medical. Device class: 2.

Clearance details

Applicant: Ab Sangtec Medical
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1990-07-24
Decision date: 1990-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

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