REP(R) IMMUNOFIX
FDA 510(k) clearance K901805 · decided 1990-06-06
Clearance details
- K-number
- K901805
- Device name
- REP(R) IMMUNOFIX
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1990-04-20
- Decision date
- 1990-06-06
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- DAH
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Beaumont, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 (K931247) | Helena Laboratories | 1993-04-27 |
| TITAN GEL (K905149) | Helena Laboratories | 1991-01-03 |
| IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (K884074) | Orion Diagnostica, Inc. | 1988-10-27 |
| TECHNICON DPA-1 IMMUNOGLOBULIN G (K883494) | Technicon Instruments Corp. | 1988-09-07 |
| TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT (K854944) | Abbott Laboratories | 1986-08-27 |
| DAKO ITA, IMMUNOGLOBULIN M (IGM) (K862184) | Dako Corp. | 1986-08-19 |
Recalls involving this device
No recalls on record reference this clearance.