FDA product code JLB: Atp And Creatine Kinase (Enzymatic), Creatine
JLB is the FDA product code for atp and creatine kinase (enzymatic), creatine. It is a Class I device, regulated under 21 CFR 862.1210 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under JLB, from 3 different applicants. The average 510(k) review took 53 days (median 63). FDA has posted 2 recalls for JLB devices.
Classification
| Field | Value |
|---|---|
| Device name | Atp And Creatine Kinase (Enzymatic), Creatine |
| Device class | Class I |
| Regulation | 21 CFR 862.1210 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Top JLB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abaxis, Inc. | 1 | 1999-08-26 |
| Olympus America, Inc. | 1 | 1997-06-11 |
| Boehringer Mannheim Corp. | 1 | 1979-03-02 |
Most recent JLB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992140 | Abaxis, Inc. | PICCOLO METLYTE 7 REAGENT DISC | 1999-08-26 | 63 |
| K971817 | Olympus America, Inc. | OLYMPUS CK-MB REAGENT | 1997-06-11 | 26 |
| K782156 | Boehringer Mannheim Corp. | UNITEST CREATINE KINASE | 1979-03-02 | 70 |
Recalls for JLB devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-04-21.
Frequently asked questions
What is FDA product code JLB?
JLB is the FDA product code for atp and creatine kinase (enzymatic), creatine. It is a Class I device, regulated under 21 CFR 862.1210 and reviewed by the Clinical Chemistry panel.
What device class is JLB?
Class I, regulation 21 CFR 862.1210. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JLB?
Across 3 cleared submissions the average was 53 days from receipt to decision (median 63).
Which companies have the most JLB clearances?
Abaxis, Inc. (1); Olympus America, Inc. (1); Boehringer Mannheim Corp. (1).
Have JLB devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2008-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code JLB
- Run a recall and safety report across every JLB manufacturer
- Watch product code JLB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Chemistry product codes · FDA product code lookup