MDI DS-DNA TEST
FDA 510(k) clearance K000477 · decided 2000-03-01
Clearance details
- K-number
- K000477
- Device name
- MDI DS-DNA TEST
- Applicant
- Micro Detect, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-02-14
- Decision date
- 2000-03-01
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- LRM
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tustin, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IMMULISA DSDNA ANTIBODY ELISA (K101319) | Immco Diagnostics, Inc. | 2010-12-09 |
| EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) (K083381) | Euroimmun Us, Inc. | 2009-04-15 |
| FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT (K062183) | The Binding Site, Ltd. | 2006-11-21 |
| VARELISA SSDNA ANTIBODIES, MODEL 14896 (K040811) | Pharmacia Deutschland GmbH | 2004-05-13 |
| ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST (K001900) | Helix Diagnostics, Inc. | 2000-09-11 |
| DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM (K994424) | Diamedix Corp. | 2000-02-18 |
| BINDAZYME ANTI-DSDNA EIA KIT (K993727) | The Binding Site, Ltd. | 1999-12-21 |
| LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 (K984396) | Bio-Rad | 1998-12-18 |
| THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET (K983422) | Zeus Scientific, Inc. | 1998-11-18 |
| SERAQUEST ANTI-DSDNA (K980391) | Quest Intl., Inc. | 1998-04-24 |
| IS-DSDNA TEST SYSTEM (K974694) | Diamedix Corp. | 1998-03-03 |
| HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY (K962730) | Hycor Biomedical, Inc. | 1997-03-07 |
Recalls involving this device
No recalls on record reference this clearance.