ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805
FDA 510(k) clearance K060431 · decided 2006-06-19
Clearance details
- K-number
- K060431
- Device name
- ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805
- Applicant
- Mbl International Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-02-21
- Decision date
- 2006-06-19
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- NYO
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Deer Field, IL, 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 |
|---|---|---|
| EliA RNA Pol III (K202541) | Phadia AB | 2021-09-13 |
| ImmuLisa Enhanced RNA POL III Antibody ELISA (K172078) | Immco Diagnostics, Inc. | 2018-03-30 |
| QUANTA LITE RNA POL III ELISA (K070066) | Inova Diagnostics, Inc. | 2007-04-11 |
Recalls involving this device
No recalls on record reference this clearance.