HEMOSIL F11 & FV DNA CONTROL
FDA 510(k) clearance K093737 · decided 2010-05-04
Clearance details
- K-number
- K093737
- Device name
- HEMOSIL F11 & FV DNA CONTROL
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 2009-12-04
- Decision date
- 2010-05-04
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- NZB
- Device class
- 2
- Regulation number
- 866.5910
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Bedford, MA, 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 |
|---|---|---|
| INTROL CF PANEL I CONTROL, MODEL: G106 (K083171) | Maine Molecular Quality Controls, Inc. | 2008-12-16 |
| 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.