EliA SmDP Immunoassay
FDA 510(k) K183007 · Phadia AB
510(k) numberK183007
Submission
- Device name
- EliA SmDP Immunoassay
- Applicant
- Phadia AB
Uppsala, SE - Received
- October 31, 2018
- Decision date
- December 24, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code LKP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202067 | EliA SmDP-SLKP · Traditional | Phadia AB | 07/14/2021SE |
| 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 |
| K990625 | Autostat II Anti-Sm ElisaLKP · Traditional | Cogent Diagnotics , Ltd. | 04/28/1999SE |
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Questions and answers
When was EliA SmDP Immunoassay cleared by the FDA?
EliA SmDP Immunoassay (K183007) received a 510(k) decision of Substantially Equivalent on December 24, 2018, 54 days after the submission was received.
What is the product code of K183007?
The FDA product code is LKP – Anti-Sm Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.