INTROL CF PANEL I CONTROL, MODEL: G106
FDA 510(k) clearance K083171 · decided 2008-12-16
Clearance details
- K-number
- K083171
- Device name
- INTROL CF PANEL I CONTROL, MODEL: G106
- Applicant
- Maine Molecular Quality Controls, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-27
- Decision date
- 2008-12-16
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- NZB
- Device class
- 2
- Regulation number
- 866.5910
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Scarborough, ME, 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 |
|---|---|---|
| HEMOSIL F11 & FV DNA CONTROL (K093737) | Instrumentation Laboratory CO | 2010-05-04 |
| GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL (K063224) | Gentris Corporation | 2006-12-22 |
| INTROL CF PANEL I CONTROL (DEN060007) | Maine Molecular Quality Controls, Inc. | 2006-10-12 |
Recalls involving this device
No recalls on record reference this clearance.