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Enzyme Linearity Control

by Phoenix Diagnostics, Inc.

510(k) K912718

Enzyme Linearity Control is a medical device (FDA Class I; FDA product code JJY, Multi-Analyte Controls, All Kinds (Assayed)) made by Phoenix Diagnostics, Inc., cleared under FDA 510(k) K912718 on 6 Sep 1991, active as of 22 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 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK912718 Date6 Sep 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  • Withdrawn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
JJY
Device class
Class I
Regulation
21 CFR Part 862.1660
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Devices cleared under K912718

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K912718
UDI-DISize and differences
Phoenix Diagnostics PH5009
PHOENIX DIAGNOSTICS, INC.
PH5009 / PH500900852676007070
Total Volume 5 mL
On the market

Similar devices

Other devices filed under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)).

Other devices from Phoenix Diagnostics, Inc.

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