Mdi SM Test
FDA 510(k) K994029 · Micro Detect, Inc.
510(k) numberK994029
Submission
- Device name
- Mdi SM Test
- Applicant
- Micro Detect, Inc.
Tustin, CA, US - Received
- November 26, 1999
- Decision date
- January 11, 2000
- 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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| K253367 | EliA CTD 13 ScreenLLL · Traditional | Phadia AB | 06/25/2026SE |
| K250666 | Alegria Flash CTD ScreenLLL · Traditional | Zeus Scientific | 10/22/2025SE |
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| K213403 | Aptiva CTD Essential ReagentLLL · Traditional | Inova Diagnostics, Inc. | 09/29/2023SE |
| K190710 | EliA SymphonyS ImmunoassayLLL · Traditional | Phadia AB | 11/29/2019SE |
| 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 |
|---|---|---|
| K003794 | Elisa Test, SerologyLYR · Traditional | 03/30/2001SE |
| K002359 | Mdi Gliadin G TestMST · Traditional | 10/19/2000SE |
| K002358 | Mdi Gliadin a TestMST · Traditional | 10/19/2000SE |
| K000934 | Mdi SCL-70 TestLJM · Traditional | 04/07/2000SE |
| K000477 | Mdi Ds-Dna TestLRM · Traditional | 03/01/2000SE |
| K993971 | Mdi Ss-B Test Enzyme Immunoassay for the Detection of Autoantibodies to Ss-B in Human…LLL · Traditional | 01/11/2000SE |
| K993843 | Mdi RF TestDHR · Traditional | 01/11/2000SE |
| K993636 | Mdi Ss-A TestLJM · Traditional | 01/10/2000SE |
| K993635 | Mdi Sm/Rnp TestLJM · Traditional | 01/10/2000SE |
| K973508 | Pylori Detect IggLYR · Traditional | 03/10/1998SE |
Questions and answers
When was Mdi SM Test cleared by the FDA?
Mdi SM Test (K994029) received a 510(k) decision of Substantially Equivalent on January 11, 2000, 46 days after the submission was received.
What is the product code of K994029?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.