LKP — Anti-Sm Antibody, Antigen And Control Class II
FDA Device Classification
Classification Details
- Product Code
- LKP
- Device Class
- Class II
- Regulation Number
- 866.5100
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K202067 | phadia | EliA SmDP-S | July 14, 2021 |
| K183007 | phadia | EliA SmDP Immunoassay | December 24, 2018 |
| K132631 | phadia us | EIA SMDP IMMUNOASSAY | August 29, 2014 |
| K123593 | inova diagnostics | QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP | April 17, 2013 |
| K051066 | theratest laboratories | THERATEST EL-ANA PROFILES | October 7, 2005 |
| K042629 | sweden diagnostics (germany) | VARELISA SM ANTIBODIES, MODEL 18296 | December 8, 2004 |
| K024219 | bio-rad | LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 | January 15, 2003 |
| K013263 | fred hutchinson cancer research center | FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST | July 29, 2002 |
| K000755 | rhigene | RHIGENE MESACUP2 TEST- SM | May 9, 2000 |
| K000312 | pharmacia and upjohn | VARELISA SM ANTIBODIES | March 17, 2000 |
| K990625 | cogent diagnotics | AUTOSTAT II ANTI-SM ELISA | April 28, 1999 |
| K984479 | bio-rad | LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 | December 22, 1998 |
| K983420 | zeus scientific | THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUN | November 18, 1998 |
| K980540 | quest intl | SERAQUEST ANTI-SM | June 15, 1998 |
| K980811 | quest intl | SERAQUEST ANTI-SM/RNP | May 12, 1998 |
| K954830 | orgentec | ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY | May 8, 1996 |
| K954896 | hycor biomedical | HYTEC AUTOIMMUNE KITS (SM) | March 22, 1996 |
| K940510 | helix diagnostics | ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT | April 20, 1994 |
| K930141 | elias u.s.a | SYNELISA SM ABS/RNP-SM ABS | May 11, 1993 |
| K911851 | general biometrics | IMMUNOWELL SM ANTIBODY TEST | May 7, 1991 |