INTROL CF PANEL I CONTROL
FDA 510(k) clearance DEN060007 · decided 2006-10-12
Clearance details
- K-number
- DEN060007
- Device name
- INTROL CF PANEL I CONTROL
- Applicant
- Maine Molecular Quality Controls, Inc.
- Decision
- Unknown
- Date received
- 2006-08-14
- Decision date
- 2006-10-12
- Days to decision
- 59 days
- Clearance type
- Post-NSE
- 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
+ Add to Predicate Builder ◉ Watch Maine Molecular Quality Controls
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.