LDH Isoenzyme Control

FDA 510(k) K771894 · Bio-Reagents & Diagnostics, Inc.

Substantially Equivalent

510(k) numberK771894

Submission

Device name
LDH Isoenzyme Control
Applicant
Bio-Reagents & Diagnostics, Inc.
Mchenry, IL, US
Received
October 6, 1977
Decision date
December 22, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CEX – Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1445
Specialty
Clinical Chemistry

Other 510(k)s with product code CEX

510(k)DeviceApplicantDecision
K872891Lactate Dehydrogenase Isoenzyme 1CEX · Traditional Data Medical Associates, Inc.09/16/1987SE
K851521LD-1(IMMUNO) Separation SetCEX · Traditional Seragen Diagnostics, Inc.05/10/1985SE
K842018Iso-Sep SystemCEX · Traditional Berwick Medical Products, Inc.09/28/1984SE
K821983Titan Gel LDH Isoenzyme KitCEX · Traditional Helena Laboratories12/22/1982SE
K821879Ultrachem T.P.CEX · Traditional Harleco Diagnostics07/14/1982SE
K800129Centrifichem CreatinineCEX · Traditional Union Carbide Corp.02/13/1980SE
K772356LDH Isoenzyme Column Reagent SetCEX · Traditional Worthington Biochemical Corp.01/24/1978SE

More from Worthington Biochemical Corp.

510(k)DeviceDecision
K781702Calibrator, Bovine SerumJIX · Traditional 11/15/1978SE
K770555CPK Isoenzyme ControlJJT · Traditional 06/03/1977SE
K760730Anticonvulsant Control SerumLAS · Traditional 10/07/1976SE

Questions and answers

When was LDH Isoenzyme Control cleared by the FDA?

LDH Isoenzyme Control (K771894) received a 510(k) decision of Substantially Equivalent on December 22, 1977, 77 days after the submission was received.

What is the product code of K771894?

The FDA product code is CEX – Chromatographic Separation, Lactate Dehydrogenase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1445.