Synelisa SM Abs/Rnp-Sm Abs
FDA 510(k) K930141 · Elias U.S.A., Inc.
510(k) numberK930141
Submission
- Device name
- Synelisa SM Abs/Rnp-Sm Abs
- Applicant
- Elias U.S.A., Inc.
Osceola, WI, US - Received
- January 12, 1993
- Decision date
- May 11, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LKP – Anti-Sm Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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| 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 |
|---|---|---|
| K964385 | Elias ANA-HEP-2LJM · Traditional | 03/06/1997SE |
| K963291 | Varelisa Ana (4) ProfileLJM · Traditional | 09/30/1996SE |
| K953873 | Varelisa Helicobacter Pylori AntibodiesLYR · Traditional | 08/30/1996SE |
| K953587 | Varelisa Mpo-AncaMOB · Traditional | 01/26/1996SE |
| K953586 | Varelisa PR3-ANCAMOB · Traditional | 01/26/1996SE |
| K951187 | Varelisa Cardiolipin Abs ScreenMID · Traditional | 10/02/1995SE |
| K951207 | Varelisa Histone AntibodiesLJM · Traditional | 04/17/1995SE |
| K951206 | Varelisa Parietal Cell AntibodiesMLE · Traditional | 04/17/1995SE |
| K951205 | Varelisa Ana ProfileLJM · Traditional | 04/17/1995SE |
| K951186 | Varelisa ANA-4 ScreenLJM · Traditional | 04/17/1995SE |
Questions and answers
When was Synelisa SM Abs/Rnp-Sm Abs cleared by the FDA?
Synelisa SM Abs/Rnp-Sm Abs (K930141) received a 510(k) decision of Substantially Equivalent on May 11, 1993, 119 days after the submission was received.
What is the product code of K930141?
The FDA product code is LKP – Anti-Sm Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.