CEX
8 FDA 510(k) clearances · Product code
55 daysmedian time to decision
169 days90th percentile
8clearances measured
FDA profile
- Official device name
- Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1445
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LACTATE DEHYDROGENASE ISOENZYME 1 (K872891) | Data Medical Associates, Inc. | 1987-09-16 |
| LD-1(IMMUNO) SEPARATION SET (K851521) | Seragen Diagnostics, Inc. | 1985-05-10 |
| ISO-SEP SYSTEM (K842018) | Berwick Medical Products, Inc. | 1984-09-28 |
| TITAN GEL LDH ISOENZYME KIT (K821983) | Helena Laboratories | 1982-12-22 |
| ULTRACHEM T.P. (K821879) | Harleco Diagnostics | 1982-07-14 |
| CENTRIFICHEM CREATININE (K800129) | Union Carbide Corp. | 1980-02-13 |
| LDH ISOENZYME COLUMN REAGENT SET (K772356) | Worthington Biochemical Corp. | 1978-01-24 |
| LDH ISOENZYME CONTROL (K771894) | Bio-Reagents & Diagnostics, Inc. | 1977-12-22 |
Track CEX automatically
Every clearance here is in the API, with alerts when new ones post.