510(k) K093737
- Device
- HEMOSIL F11 & FV DNA CONTROL
- Applicant
- INSTRUMENTATION LABORATORY CO.
- 510(k) number
- K093737
- Product code
- NZB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-05-04
- Date received
- 2009-12-04
- Regulation
- 866.5910
- Classification name
- Quality Control Material, Genetics, Dna
- Medical specialty
- Microbiology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROL MARBLE
- Address
- 180 Bedford Rd. Bedford MA US 01730 01730
FDA Registration Numbers#
- 3014150341
- 3014673819
- 3022778613
- 2431530
- 3005959679
- 3017467459
Source Documents#
Other 510(k) Records For Product Code NZB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K083171 | INTROL CF PANEL I CONTROL, MODEL: G106 | Maine Molecular Quality Controls, Inc. | 2008-12-16 |
| K063224 | GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL | Gentris Corporation | 2006-12-22 |
| DEN060007 | INTROL CF PANEL I CONTROL | Maine Molecular Quality Controls, Inc. | 2006-10-12 |
Legacy Summary#
summary
FDA Review#
Decision Summary