Dried Gram-Negative and Gram-Positive Mic/Combo Panels

by Dade Behring, Inc. 510(k)

Active United States

510(k) K010418

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK010418	Date22 Aug 2001Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number: K010418
FDA Product Code: LTT

Device Class: Class II
Regulation: 21 CFR Part 866.1640
Advisory Committee: Microbiology
FDA Decision: SESE Substantially Equivalent

Other devices from Dade Behring, Inc.

Apolipoprotein Control Serum Chd, Model Ouph

Class I
Dade Tru-Liquid Cardiac Control

Class I
Stratus Cs Acute Care Troponin I Testpak, Model Cctni

Class II
Behring Coagulation System, Model BCS

Class II
Modification to N Protein Standard Sl

Class II
Tgl Flex Reagent Cartridge

Class I

See all devices from Dade Behring, Inc. →