LIPOGEN ANA TEST KIT
FDA 510(k) clearance K875246 · decided 1988-02-10
Clearance details
- K-number
- K875246
- Device name
- LIPOGEN ANA TEST KIT
- Applicant
- Lipogen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-22
- Decision date
- 1988-02-10
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- LJM
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Knoxville, TN, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
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| ELIA SCL-70S IMMUNOASSAY (K140493) | Phadia GmbH | 2014-10-30 |
| QUANTA FLASH CENTROMERE (K123880) | Inova Diagnostics, Inc. | 2014-02-07 |
| GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT (K131330) | Gold Standard Diagnostics | 2014-01-28 |
| ANA SCREEN ELISA (IGG) (K131185) | Euroimmun US | 2013-07-15 |
| VARELISA RECOMBI ANA SCREEN, MODEL 12 596 (K083188) | Phadia US, Inc. | 2009-03-13 |
| VARELISA RECOMBI CTD SCREEN, MODEL 13096 (K050967) | Sweden Diagnostics (Germany) GmbH | 2005-06-28 |
| VARELISA RECOMBI ANA PROFILE, MODEL 18496 (K050625) | Sweden Diagnostics (Germany) GmbH | 2005-04-26 |
| IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA (K041102) | Immco Diagnostics, Inc. | 2004-10-26 |
| AESKULISA ANA HEP-2 (K040953) | Aesku, Inc. | 2004-06-23 |
| VARELISA HISTONE ANTIBODIES, MODEL 16496 (K040810) | Pharmacia Deutschland GmbH | 2004-05-14 |
Recalls involving this device
No recalls on record reference this clearance.