AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
FDA 510(k) clearance K991890 · decided 1999-08-09
Clearance details
- K-number
- K991890
- Device name
- AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
- Applicant
- Cogent Diagnotics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-03
- Decision date
- 1999-08-09
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- MVJ
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Midlothian, Scotland, GB
- 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 |
|---|---|---|
| ATHENA MULTI-LYTE GBM TEST SYSTEM (K071219) | Zeus Scientific, Inc. | 2007-12-06 |
| BIOPLEX VASCULITIS KIT (K072358) | Bio-Rad Laboratories | 2007-10-31 |
| PHASE II GBM IGG ANTIBODY EIA TEST (K011348) | Scimedx Corp. | 2001-06-25 |
| BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT (K984619) | The Binding Site, Ltd. | 1999-02-23 |
| QUANTA LITE GBM ELISA (K984336) | Inova Diagnostics, Inc. | 1999-02-08 |
Recalls involving this device
No recalls on record reference this clearance.