Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
The Chromatographic Separation Lactate Dehydrogenase Isoenzymes Test is a clinical chemistry device that uses chromatographic separation techniques to distinguish and quantify individual LDH isoenzyme fractions from biological samples, providing more specific information than total LDH measurements for diagnosing the source and nature of tissue injury. It is classified as FDA Class 2 (moderate risk), though it is exempt from 510(k) premarket notification. The product code is CEX, regulated under 21 CFR 862.1445, within the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- CEX
- 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 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K872891 | LACTATE DEHYDROGENASE ISOENZYME 1 | Sep 16, 1987 | Substantially Equivalent | Data Medical Associates, Inc. |
| K851521 | LD-1(IMMUNO) SEPARATION SET | May 10, 1985 | Substantially Equivalent | Seragen Diagnostics, Inc. |
| K842018 | ISO-SEP SYSTEM | Sep 28, 1984 | Substantially Equivalent | Berwick Medical Products, Inc. |
| K821983 | TITAN GEL LDH ISOENZYME KIT | Dec 22, 1982 | Substantially Equivalent | Helena Laboratories |
| K821879 | ULTRACHEM T.P. | Jul 14, 1982 | Substantially Equivalent | Harleco Diagnostics |
| K800129 | CENTRIFICHEM CREATININE | Feb 13, 1980 | Substantially Equivalent | Union Carbide Corp. |
| K772356 | LDH ISOENZYME COLUMN REAGENT SET | Jan 24, 1978 | Substantially Equivalent | Worthington Biochemical Corp. |
| K771894 | LDH ISOENZYME CONTROL | Dec 22, 1977 | Substantially Equivalent | Bio-Reagents & Diagnostics, Inc. |
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.