Atp And Creatine Kinase (Enzymatic), Creatine
This device is a clinical chemistry reagent system that measures creatine using ATP and creatine kinase in an enzymatic reaction monitored by ultraviolet spectrophotometry, providing a highly specific method for quantifying creatine in serum or urine to assess muscle metabolism and energy homeostasis. It is classified as FDA Class 1, subject only to general controls with no premarket submission required. The product code is JLB, regulated under 21 CFR 862.1210, and assigned to the Clinical Chemistry medical specialty.
Basic Information
- Product Code
- JLB
- Device Class
- FDA class 1
- Regulation Number
- 862.1210
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K992140 | PICCOLO METLYTE 7 REAGENT DISC | Aug 26, 1999 | Substantially Equivalent | Abaxis, Inc. |
| K971817 | OLYMPUS CK-MB REAGENT | Jun 11, 1997 | Substantially Equivalent | Olympus America, Inc. |
| K782156 | UNITEST CREATINE KINASE | Mar 02, 1979 | Substantially Equivalent | Boehringer Mannheim Corp. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.