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Color-Monogen

by Instrumentation Laboratory CO

510(k) K012901

Color-Monogen is a Class II device made by Instrumentation Laboratory CO, cleared under FDA 510(k) K012901 on 27 Sep 2001, 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 NumberK012901 Date27 Sep 2001ClearedStatusActive

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  • Withdrawn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
KTN
Device class
Class II
Regulation
21 CFR Part 866.5640
Advisory committee
Immunology
FDA decision
SESE Substantially Equivalent

Devices cleared under K012901

4 devices · 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 K012901
UDI-DISize and differences
Sure-Vue T3018-1004
FISHER SCIENTIFIC COMPANY L.L.C.
23038016 / T3018-100400006136471196 —On the market
Sure-Vue T3018-1004
FISHER SCIENTIFIC COMPANY L.L.C.
23038016 / T3018-100400613647001196 —On the market
Sure-Vue T3018-1005
FISHER SCIENTIFIC COMPANY L.L.C.
23038017 / T3018-100500006136471202 —On the market
Sure-Vue T3018-1005
FISHER SCIENTIFIC COMPANY L.L.C.
23038017 / T3018-100500613647001202 —On the market

Similar devices

Other devices filed under FDA product code KTN (System, Test, Infectious Mononucleosis).

Other devices from Instrumentation Laboratory Company

See all devices from Instrumentation Laboratory Company →