LKP — Anti-Sm Antibody, Antigen And Control Class II
FDA product code LKP covers "Anti-Sm Antibody, Antigen And Control", a Class II medical device regulated under 21 CFR 866.5100. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K911848 | general biometrics | IMMUNOWELL RNP/SM ANTIBODY TEST | May 7, 1991 |