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Diascreen Reagent Strips

by Chronimed, Inc.

510(k) K981555

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981555 Date1 Jun 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2634-2010 FDA Unclassified (pre-2012) initiated 24 Mar 2010

    This recall has been initiated due to a labeling issue with the Hypoguard DiaScreen 4-way pH 100 strips. The front and back panel of the bottle carton lists five reagents when it should only list four reagents. The Ketone reagent should not be included on the label. The test strips contained in the bottle and all other labeling are correct and properly align with 4pH part number D11400 listed on

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  • Withdrawn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
LJX
Device Class
Class I
Regulation
21 CFR Part 864.7675
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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