Skip to content

Enzymatics, Inc., Total Cholesterol Test

by Enzymatics C/O Burditt, Bowles, Radzius & Ruberry

510(k) K911692

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK911692 Date16 Aug 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
CHH
FDA applicant
Enzymatics C/O Burditt,Bowles,Radzius & Ruberry
Device Class
Class I
Regulation
21 CFR Part 862.1175
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Enzymatics C/O Burditt, Bowles, Radzius & Ruberry