510(k) DEN060007
- Device
- INTROL CF PANEL I CONTROL
- Applicant
- Maine Molecular Quality Controls, Inc.
- 510(k) number
- DEN060007
- Product code
- NZB
- Decision
- Unknown (DENG)
- Decision date
- 2006-10-12
- Date received
- 2006-08-14
- Regulation
- 866.5910
- Classification name
- Quality Control Material, Genetics, Dna
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- JOAN GORDON
- Address
- 10 Southgate Rd. Scarborough ME US 04074 04074
FDA Registration Numbers#
- 3014150341
- 3014673819
- 3022778613
- 2431530
- 3005959679
- 3017467459
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NZB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093737 | HEMOSIL F11 & FV DNA CONTROL | Instrumentation Laboratory CO | 2010-05-04 |
| 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 |