Emit 2000 Procainamide Assay, Model OSR4K229

by Syva Co., Dade Behring, Inc. 510(k)

Active United States

510(k) K010812

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK010812	Date13 Apr 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Withdrawn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 11 Oct 2026.

Specification

510(k)

510(k) Number: K010812
FDA Product Code: LAR

Device Class: Class II
Regulation: 21 CFR Part 862.3320
Advisory Committee: Clinical Toxicology
FDA Decision: SESE Substantially Equivalent

Other devices from Syva Co., Dade Behring, Inc.

Syva Emit 2000 Thyroxine Assay, Calibrators

Class II
Emit Ii Plus Opiate Assay, Model OSR9B229

Class II
Emit 2000 Digoxin Assay, Model OSR4H229

Class II
Modification to the Emit Ii Plus Phencyclidine Assay, Model OSR9J229

Unclassified
Modification to the Emit Ii Plus Propoxyphene Assay, Model OSR9G229

Class II
Emit Ii Plus Cannabinoid Assay, Model OSR9N229

Class II

See all devices from Syva Co., Dade Behring, Inc. →