Enzyme Immunoassay Anti-Sm Antibody Test Kit
FDA 510(k) K940510 · Helix Diagnostics, Inc.
510(k) numberK940510
Submission
- Device name
- Enzyme Immunoassay Anti-Sm Antibody Test Kit
- Applicant
- Helix Diagnostics, Inc.
West Sacramento, CA, US - Received
- February 4, 1994
- Decision date
- April 20, 1994
- 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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| 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 |
|---|---|---|
| K001900 | Enzyme Immunoassay Anti-Ssdna Antibody TestLRM · Traditional | 09/11/2000SE |
| K000489 | Enzyme Immunoassay Anti-Centromere Antibody TestLLL · Traditional | 04/05/2000SE |
| K980337 | Diamedix Immunosimplicity Ana (Is-Ana) Screen Test SystemLJM · Traditional | 05/12/1998SE |
| K960091 | Enzyme Immunoassay Anti-Double Stranded DNA (Dsdna) Test KitLRM · Traditional | 03/20/1996SE |
| K954723 | Enzyme Immunoassay Ana Screening Test KitLKJ · Traditional | 12/15/1995SE |
| K954700 | Enzyme Immunoassay Lupus Screen Test KitLKJ · Traditional | 12/15/1995SE |
| K952253 | Enzyme Immunoassay Ena Plus Screening Test KitLLL · Traditional | 08/24/1995SE |
| K951850 | Enzyme Immunoassay ANTI-JO-1 Antibody Test KitLJM · Traditional | 07/18/1995SE |
| K951798 | Enzyme Immunoassay ANTI-SCI-70 Antibody Test KitLJM · Traditional | 07/17/1995SE |
| K940588 | Enzyme Immunoassay Anti-Sm/Rnp Antibody Test KitLKO · Traditional | 04/20/1994SE |
Questions and answers
When was Enzyme Immunoassay Anti-Sm Antibody Test Kit cleared by the FDA?
Enzyme Immunoassay Anti-Sm Antibody Test Kit (K940510) received a 510(k) decision of Substantially Equivalent on April 20, 1994, 75 days after the submission was received.
What is the product code of K940510?
The FDA product code is LKP – Anti-Sm Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.