DAH — Gamma Globulin, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DAH
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K931247 | helena laboratories | TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 | April 27, 1993 |
| K905149 | helena laboratories | TITAN GEL | January 3, 1991 |
| K901805 | helena laboratories | REP(R) IMMUNOFIX | June 6, 1990 |
| K884074 | orion diagnostica | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G | October 27, 1988 |
| K883494 | technicon instruments | TECHNICON DPA-1 IMMUNOGLOBULIN G | September 7, 1988 |
| K854944 | abbott laboratories | TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT | August 27, 1986 |
| K862184 | dako | DAKO ITA, IMMUNOGLOBULIN M (IGM) | August 19, 1986 |