Skip to content

Phospholipid Reagent Set

by Sterling Diagnostics Inc

510(k) K914040

Phospholipid Reagent Set is a Class I device made by Sterling Diagnostics Inc, cleared under FDA 510(k) K914040 on 30 Oct 1991, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK914040 Date30 Oct 1991ClearedStatusActive

Official records

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  • Withdrawn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
JNT
FDA applicant
Sterling Diagnostics, Inc.
Device class
Class I
Regulation
21 CFR Part 862.1575
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Other devices from Sterling Diagnostics Inc

See all devices from Sterling Diagnostics Inc →