CEX — Chromatographic Separation, Lactate Dehydrogenase Isoenzymes Class II
FDA Device Classification
Classification Details
- Product Code
- CEX
- Device Class
- Class II
- Regulation Number
- 862.1445
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K872891 | data medical associates | LACTATE DEHYDROGENASE ISOENZYME 1 | September 16, 1987 |
| K851521 | seragen diagnostics | LD-1(IMMUNO) SEPARATION SET | May 10, 1985 |
| K842018 | berwick medical products | ISO-SEP SYSTEM | September 28, 1984 |
| K821983 | helena laboratories | TITAN GEL LDH ISOENZYME KIT | December 22, 1982 |
| K821879 | harleco diagnostics | ULTRACHEM T.P. | July 14, 1982 |
| K800129 | union carbide | CENTRIFICHEM CREATININE | February 13, 1980 |
| K772356 | worthington biochemical | LDH ISOENZYME COLUMN REAGENT SET | January 24, 1978 |
| K771894 | bio-reagents and diagnostics | LDH ISOENZYME CONTROL | December 22, 1977 |