510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
JLBClass I

Atp And Creatine Kinase (Enzymatic), Creatine

21 CFR 862.1210 / Clinical Chemistry
FDA source (opens on fda.gov)

JLB is the FDA product code for Atp And Creatine Kinase (Enzymatic), Creatine, a class I device type, regulated under 21 CFR 862.1210. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
JLB
Device name
Atp And Creatine Kinase (Enzymatic), Creatine
Regulation
21 CFR 862.1210
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
2

Clearances, product code JLB

By decision year
3 clearances under product code JLB with a decision year between 1979 and 1999, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JLB by decision year
YearClearances
19791
19971
19991

Applicants with the most clearances

Product code JLB
Applicants holding the most 510(k) clearances under product code JLB
ApplicantClearances
Abaxis Inc1
Boehringer Mannheim Corp.1
OLYMPUS Corporation of the Americas1

Companies listing this code with FDA

Companies whose registered establishments list this code