EUROIMMUN Anti-BP230-CF ELISA (IgG)
FDA 510(k) clearance K193115 · decided 2020-09-17
Clearance details
- K-number
- K193115
- Device name
- EUROIMMUN Anti-BP230-CF ELISA (IgG)
- Applicant
- Euroimmun Us, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-11-12
- Decision date
- 2020-09-17
- Days to decision
- 310 days
- Clearance type
- Traditional
- Product code
- OEG
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mountain Lakes, 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 |
|---|---|---|
| EUROIMMUN ANTI BP 180-4X ELISA (IGG) (K083615) | Euroimmun Us, Inc. | 2009-03-16 |
| MESACUP MODELS BP180 AND BP230 ELISA KITS (K071961) | Mbl International Corporation | 2008-08-25 |
Recalls involving this device
No recalls on record reference this clearance.