Serum, Lactic Dehydrogenase

by Fisher Scientific Co., LLC 510(k)

Active United States

510(k) K790020

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK790020	Date8 Feb 1979Cleared	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Withdrawn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 22 Oct 2026.

Specification

510(k)

510(k) Number: K790020
FDA Product Code: CFJ

Device Class: Class II
Regulation: 21 CFR Part 862.1440
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

Other devices from Fisher Scientific Co., LLC

Total Bilirubin

Class II
Calibrating Solution for Abl-1 & 2

Class II
Reagent for Coulter Counter Model 5+11

Class I
Total Protein Reagent Cs-724

Class II
Cleaning Solution For Radiometer OSM2

Class II
Diagnostics Po 2 Electrolyte

Class II

See all devices from Fisher Scientific Co., LLC →