Diastat Ena Single Well Screen Kit
FDA 510(k) K944505 · Shield Diagnostics, Ltd.
510(k) numberK944505
Submission
- Device name
- Diastat Ena Single Well Screen Kit
- Applicant
- Shield Diagnostics, Ltd.
Dundee, GB - Received
- September 14, 1994
- Decision date
- November 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
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| 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 |
|---|---|---|
| K000398 | Shield Von Willebrand Factor Activity Elisa, Model FVWF 200GGP · Traditional | 04/17/2000SE |
| K982879 | Shield Diastat ANTI-B2 Glycoprotein 1 Igg (Elisa) AssayMSV · Traditional | 10/15/1998SE |
| K980885 | Shield Activated Factor Xii (Elisa) AssayGGP · Traditional | 08/21/1998SE |
| K972981 | Shield HELICO-G2 Elisa KitLYR · Traditional | 03/17/1998SE |
| K962825 | Shield Von Willebrand Factor Activity (Elisa) AssayGGP · Traditional | 11/15/1996SE |
| K963525 | Diastat Anti-Glomerular Basement Membrane KitDBL · Traditional | 11/07/1996SE |
| K961515 | Quantase Phenylalanine AssayJNB · Traditional | 06/12/1996SE |
| K955303 | Diastat Anti-Cardiolipin KitMID · Traditional | 05/30/1996SE |
| K952183 | Diastat Anti-Thyroglobulin KitJZO · Traditional | 06/30/1995SE |
| K951487 | Diastat Anti-Thyroid Peroxidase KitJZO · Traditional | 06/30/1995SE |
Questions and answers
When was Diastat Ena Single Well Screen Kit cleared by the FDA?
Diastat Ena Single Well Screen Kit (K944505) received a 510(k) decision of Substantially Equivalent on November 21, 1994, 68 days after the submission was received.
What is the product code of K944505?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.