FDA Product Code
FDA Product Code CEX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1445
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K872891 | LACTATE DEHYDROGENASE ISOENZYME 1 | Data Medical Associates, Inc. | 1987-09-16 | Traditional | PDF ↗ |
| K851521 | LD-1(IMMUNO) SEPARATION SET | Seragen Diagnostics, Inc. | 1985-05-10 | Traditional | PDF ↗ |
| K842018 | ISO-SEP SYSTEM | Berwick Medical Products, Inc. | 1984-09-28 | Traditional | PDF ↗ |
| K821983 | TITAN GEL LDH ISOENZYME KIT | Helena Laboratories | 1982-12-22 | Traditional | PDF ↗ |
| K821879 | ULTRACHEM T.P. | Harleco Diagnostics | 1982-07-14 | Traditional | PDF ↗ |
| K800129 | CENTRIFICHEM CREATININE | Union Carbide Corp. | 1980-02-13 | Traditional | PDF ↗ |
| K772356 | LDH ISOENZYME COLUMN REAGENT SET | Worthington Biochemical Corp. | 1978-01-24 | Traditional | PDF ↗ |
| K771894 | LDH ISOENZYME CONTROL | Bio-Reagents & Diagnostics, Inc. | 1977-12-22 | Traditional | PDF ↗ |
Product code CEX · Class II · Clinical Chemistry. Data: openFDA.