SM Antibody Test Kit
FDA 510(k) K880254 · Lipogen, Inc.
510(k) numberK880254
Submission
- Device name
- SM Antibody Test Kit
- Applicant
- Lipogen, Inc.
Knoxville, TN, US - Received
- January 20, 1988
- Decision date
- April 6, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKP – Anti-Sm Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code LKP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202067 | EliA SmDP-SLKP · Traditional | Phadia AB | 07/14/2021SE |
| K183007 | EliA SmDP ImmunoassayLKP · Traditional | Phadia AB | 12/24/2018SE |
| K132631 | Eia SMDP ImmunoassayLKP · Traditional | Phadia US, Inc. | 08/29/2014SE |
| K123593 | Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP…LKP · Traditional | Inova Diagnostics, Inc. | 04/17/2013SE |
| K051066 | Theratest El-Ana ProfilesLKP · Traditional | Theratest Laboratories, Inc. | 10/07/2005SE |
| K042629 | Varelisa SM Antibodies, Model 18296LKP · Traditional | Sweden Diagnostics (Germany) GmbH | 12/08/2004SE |
| K024219 | Liquichek Anti-Sm Control, Positive, Catalog #115LKP · Traditional | Bio-Rad | 01/15/2003SE |
| K013263 | Fred Hutchinson Cancer Research Center Enzyme Anti-Sr Protein Antibody TestLKP · Traditional | Fred Hutchinson Cancer Research Center | 07/29/2002SE |
| K000755 | Rhigene MESACUP2 Test- SMLKP · Traditional | Rhigene, Inc. | 05/09/2000SE |
| K000312 | Varelisa SM AntibodiesLKP · Traditional | Pharmacia & Upjohn Co. | 03/17/2000SE |
More from Pharmacia & Upjohn Co.
| 510(k) | Device | Decision |
|---|---|---|
| K902636 | Lipogen Rheumelisa Dsdna AssayLRY · Traditional | 06/28/1990SE |
| K895997 | Rheumelisa Assay for RNP AutoantibodiesLKO · Traditional | 11/06/1989SE |
| K895996 | Rheumelisa Assay for SM AutoantibodiesLKP · Traditional | 11/06/1989SE |
| K895995 | Rheumelisa Assay for Ss-B/La AutoantibodiesLJM · Traditional | 10/27/1989SE |
| K895994 | Rheumelisa Assay for Ss-A/Ro AutoantibodiesLJM · Traditional | 10/24/1989SE |
| K894659 | Ana Antisera Control KitDHN · Traditional | 09/21/1989SE |
| K892421 | Modified Access R-Clone Ana/Rf Screening TestLJM · Traditional | 05/09/1989SE |
| K885048 | Access R-Clone Ana Profile AssayDHC · Traditional | 01/24/1989SE |
| K882740 | Access R-Clone(Tm) Ana/Rf Screening AssayLKJ · Traditional | 09/22/1988SE |
| K874195 | La Antibody Test KitLJM · Traditional | 03/11/1988SE |
Questions and answers
When was SM Antibody Test Kit cleared by the FDA?
SM Antibody Test Kit (K880254) received a 510(k) decision of Substantially Equivalent on April 6, 1988, 77 days after the submission was received.
What is the product code of K880254?
The FDA product code is LKP – Anti-Sm Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.