EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
FDA 510(k) clearance K091969 · decided 2010-09-02
Clearance details
- K-number
- K091969
- Device name
- EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
- Applicant
- Euroimmun Us, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-01
- Decision date
- 2010-09-02
- Days to decision
- 428 days
- Clearance type
- Traditional
- Product code
- NBO
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Morristown, NJ, 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 |
|---|---|---|
| RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E (K000336) | Rhigene, Inc. | 2000-06-09 |
Recalls involving this device
No recalls on record reference this clearance.