DIGENE CERVICAL BRUSH— 510(k) K971586

Substantially Equivalent

Digene Corp.

FDA 510(k) clearance K971586 for DIGENE CERVICAL BRUSH, Substantially Equivalent on 1997-09-19. Applicant: Digene Corp.. Device class: 2.

Clearance details

Applicant: Digene Corp.
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1997-05-01
Decision date: 1997-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beltsville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HHT

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More clearances from Digene Corp.

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K981567 — HYBRID CAPTURE II CT/GC TEST2000-02-29
K981485 — HYBRID CAPTURE II GC-ID1999-11-29

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