Enzyme Immunoassay Ena Plus Screening Test Kit
FDA 510(k) K952253 · Helix Diagnostics, Inc.
510(k) numberK952253
Submission
- Device name
- Enzyme Immunoassay Ena Plus Screening Test Kit
- Applicant
- Helix Diagnostics, Inc.
West Sacramento, CA, US - Received
- May 15, 1995
- Decision date
- August 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LLL – Extractable Antinuclear Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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| K250666 | Alegria Flash CTD ScreenLLL · Traditional | Zeus Scientific | 10/22/2025SE |
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| K180975 | QUANTA Flash HMGCR ReagentsLLL · Traditional | Inova Diagnostics, Inc. | 06/25/2018SE |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsLLL · Traditional | Inova Diagnostics, Inc. | 06/01/2016SE |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsLLL · Traditional | Inova Diagnostics, Inc. | 02/12/2016SE |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA…LLL · Traditional | Immco Diagnostics, Inc. | 03/31/2015SE |
More from Immco Diagnostics, Inc.
| 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 |
| 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 |
| K940510 | Enzyme Immunoassay Anti-Sm Antibody Test KitLKP · Traditional | 04/20/1994SE |
Questions and answers
When was Enzyme Immunoassay Ena Plus Screening Test Kit cleared by the FDA?
Enzyme Immunoassay Ena Plus Screening Test Kit (K952253) received a 510(k) decision of Substantially Equivalent on August 24, 1995, 101 days after the submission was received.
What is the product code of K952253?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.