Skip to content

Quantase Phenylalanine Screening Assay 500 Test Kit

by Quantase, Ltd.

510(k) K000754

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000754 Date19 Jun 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1562-2011 FDA Unclassified (pre-2012) initiated 26 Jan 2010

    Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.

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  • Withdrawn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
JNB
FDA applicant
Quantase , Ltd.
Device Class
Class II
Regulation
21 CFR Part 862.1555
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Quantase, Ltd.