Skip to content

Whatman Body Fluid Collection Paper:whatman BFC180

by Whatman Specialty Products, Inc.

510(k) K932661

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932661 Date17 Apr 1996ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-2384-2010 FDA Unclassified (pre-2012) initiated 29 Oct 2009 on shared 510(k) K932661

    Neonate newborn screening card demographic and filter portion may be detached

    • Terminated Z-1005-2010 FDA Unclassified (pre-2012) initiated 19 May 2009 on shared 510(k) K932661

    '903' newborn Neonate screening cards have duplicate numbers assigned on cards and may result in cross-over of patient test results

    • Terminated Z-1871-2009 FDA Unclassified (pre-2012) initiated 6 May 2009 on shared 510(k) K932661

    The two portions of the card are coming apart prematurely.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PJC
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent