Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
Differential Rate Kinetic Method for Lactate Dehydrogenase Isoenzymes is a clinical chemistry test system that measures the relative activities of LDH isoenzyme fractions in serum using kinetic rate differentiation, used in diagnosing myocardial infarction, liver disease, and hemolytic disorders. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. The product code is JGF, regulated under 21 CFR 862.1445, within the Clinical Chemistry medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- JGF
- Device Class
- FDA class 2
- Regulation Number
- 862.1445
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K981338 | LD-1 | May 18, 1998 | Substantially Equivalent | ABBOTT LABORATORIES |
| K925188 | ABBOTT QUICKSTART LD-1, MODIFICATION | Feb 05, 1993 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K914261 | ABBOTT QUICKSTART LD-1,#5A30 | Oct 21, 1991 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K890996 | LD1 ISOENZYME REAGENT KIT | May 05, 1989 | Substantially Equivalent | TRACE SCIENTIFIC LTD. |
| K871240 | ABBOTT A-GENT LD-1 ISOZYME REAGENT | May 13, 1987 | Substantially Equivalent | ABBOTT LABORATORIES |
| K860367 | MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) | Apr 11, 1986 | Substantially Equivalent | ALPKEM CORP. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.