Autostat II Anti-Sm Elisa
FDA 510(k) K990625 · Cogent Diagnotics , Ltd.
510(k) numberK990625
Submission
- Device name
- Autostat II Anti-Sm Elisa
- Applicant
- Cogent Diagnotics , Ltd.
Midlothian, Scotland, GB - Received
- February 25, 1999
- Decision date
- April 28, 1999
- 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 |
|---|---|---|
| K003057 | Autostat II ENA-4 Profile ElisaLLL · Traditional | 10/13/2000SE |
| K003054 | Autostat II ENA-6 Profile ElisaLLL · Traditional | 10/13/2000SE |
| K002215 | Autostat II Anti-Myeloperoxidase (Mpo) ElisaMOB · Traditional | 09/28/2000SE |
| K993557 | Autostat II Rheumatoid Factor Iga ElisaDHR · Traditional | 03/03/2000SE |
| K994338 | Autostat II Rheumatoid Factor Igm ElisaDHR · Traditional | 02/03/2000SE |
| K993085 | Autostat II Anti-Cardiolipin Screen ElisaMID · Traditional | 02/01/2000SE |
| K993304 | Autostat II Rheumatoid Factor Igg ElisaDHR · Traditional | 12/06/1999SE |
| K992449 | Autostat II Anti-Cardiolipin Igm ElisaMID · Traditional | 11/24/1999SE |
| K993087 | Autostat II Anti-Gliadin Igg ElisaMST · Traditional | 11/12/1999SE |
| K993086 | Autostat II Anti-Gliadin Iga ElisaMST · Traditional | 11/12/1999SE |
Questions and answers
When was Autostat II Anti-Sm Elisa cleared by the FDA?
Autostat II Anti-Sm Elisa (K990625) received a 510(k) decision of Substantially Equivalent on April 28, 1999, 62 days after the submission was received.
What is the product code of K990625?
The FDA product code is LKP – Anti-Sm Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.