FETAL D TECTION KIT— 510(k) K980314

Substantially Equivalent

Biopool Intl., Inc.

FDA 510(k) clearance K980314 for FETAL D TECTION KIT, Substantially Equivalent on 1998-04-08. Applicant: Biopool Intl., Inc.. Device class: 2.

Clearance details

Applicant: Biopool Intl., Inc.
Product code: Code LIM
Device class: Class 2
Regulation: 21 CFR 864.7455
Advisory panel: Hematology
Date received: 1998-01-27
Decision date: 1998-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, 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.