JLB · Class I · 21 CFR 862.1210

FDA Product Code JLB: Atp And Creatine Kinase (enzymatic), Creatine

Leading manufacturers include Boehringer Mannheim Corp., Olympus America, Inc. and Abaxis, Inc..

3
Total
3
Cleared
53d
Avg days
1979
Since

FDA 510(k) Cleared Atp And Creatine Kinase (enzymatic), Creatine Devices (Product Code JLB)

3 devices
1–3 of 3
Cleared Aug 26, 1999
PICCOLO METLYTE 7 REAGENT DISC
K992140
Abaxis, Inc.
Chemistry · 63d
Cleared Jun 11, 1997
OLYMPUS CK-MB REAGENT
K971817
Olympus America, Inc.
Chemistry · 26d
Cleared Mar 02, 1979
UNITEST CREATINE KINASE
K782156
Boehringer Mannheim Corp.
Chemistry · 70d

About Product Code JLB - Regulatory Context