CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY— 510(k) K942843

Name: FDA 510(k) clearance K942843
Creator: U.S. Food and Drug Administration
Published: 1994-12-08

Substantially Equivalent

Rovers Diagnostic Devices

FDA 510(k) clearance K942843 for CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY, Substantially Equivalent on 1994-12-08. Applicant: Rovers Diagnostic Devices. Device class: 2.

Clearance details

Applicant: Rovers Diagnostic Devices
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1994-06-16
Decision date: 1994-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nyack, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HHT

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K182049 — exCellerator Cervical Collection Device2019-04-25
K153128 — Kolplast Cervical Sample Collection Kit2017-01-13
K141057 — DISPOSABLE CERVICAL BRUSH2015-05-14
K111681 — HISTOBRUSH2012-01-19
K083012 — PAPCONE2009-04-09

More clearances from Rovers Diagnostic Devices

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K941472 — CERVEX-BRUSH PAP KIT1995-02-28
K942144 — URETHRA-BRUSH1994-06-27

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