FDA Product Code
FDA Product Code DAH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K931247 | TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 | Helena Laboratories | 1993-04-27 | Traditional | PDF ↗ |
| K905149 | TITAN GEL | Helena Laboratories | 1991-01-03 | Traditional | PDF ↗ |
| K901805 | REP(R) IMMUNOFIX | Helena Laboratories | 1990-06-06 | Traditional | PDF ↗ |
| K884074 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G | Orion Diagnostica, Inc. | 1988-10-27 | Traditional | PDF ↗ |
| K883494 | TECHNICON DPA-1 IMMUNOGLOBULIN G | Technicon Instruments Corp. | 1988-09-07 | Traditional | PDF ↗ |
| K854944 | TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT | Abbott Laboratories | 1986-08-27 | Traditional | PDF ↗ |
| K862184 | DAKO ITA, IMMUNOGLOBULIN M (IGM) | Dako Corp. | 1986-08-19 | Traditional | PDF ↗ |
Product code DAH · Class II · Immunology. Data: openFDA.