Varelisa SM Antibodies, Model 18296
FDA 510(k) K042629 · Sweden Diagnostics (Germany) GmbH
510(k) numberK042629
Submission
- Device name
- Varelisa SM Antibodies, Model 18296
- Applicant
- Sweden Diagnostics (Germany) GmbH
Freiburg, DE - Received
- September 27, 2004
- Decision date
- December 8, 2004
- 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
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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 |
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| 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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| K041357 | Varelisa Gliadin Igg AntibodiesMST · Traditional | 08/02/2004SE |
| K041173 | Celikey Igg Itg Igg Antibodies, Model 17996MVM · Traditional | 08/02/2004SE |
| K041174 | Celikey TTG (Human, Recombinant) Iga Antibodies Model #18148/18196MVM · Traditional | 07/19/2004SE |
| K041354 | Varelisa Gliadin Iga Antibodies Model #19848/19896MST · Traditional | 07/16/2004SE |
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Questions and answers
When was Varelisa SM Antibodies, Model 18296 cleared by the FDA?
Varelisa SM Antibodies, Model 18296 (K042629) received a 510(k) decision of Substantially Equivalent on December 8, 2004, 72 days after the submission was received.
What is the product code of K042629?
The FDA product code is LKP – Anti-Sm Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.