REP IMMUNOFIX
FDA 510(k) clearance K923658 · decided 1992-11-02
Clearance details
- K-number
- K923658
- Device name
- REP IMMUNOFIX
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1992-07-23
- Decision date
- 1992-11-02
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- CFF
- 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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| MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING (K143483) | Sebia | 2015-01-08 |
| INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT (K120169) | Grifols USA, LLC | 2012-08-24 |
| THE HELENA V8 IMMUNODISPLACEMENT KIT (K111369) | Helena Laboratories Uk, Ltd. | 2012-06-26 |
| IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT (K103757) | Grifols | 2011-10-13 |
| CAPILLARYS IMMUNOTYPING, MODEL 2100 (K082085) | Sebia | 2009-04-17 |
| MINICAP IMMUNOTYPING, MODEL: 2300 (K082388) | Sebia | 2009-04-14 |
| SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 (K061069) | Helena Laboratories | 2006-07-06 |
Recalls involving this device
No recalls on record reference this clearance.