510(k) K083430
K083430 is an FDA 510(k) premarket notification submitted by Nanogen, Inc. for the device "REAL-TIME PCR INTERNAL CONTROL 2B SET". The FDA issued a decision of Substantially Equivalent on January 15, 2009. The device falls under product code OLD (Internal Polymerase Chain Reaction Control, Not Assay Specific), a Class I device regulated under 21 CFR 862.1660. Nanogen, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 2009
- Date Received
- November 19, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Internal Polymerase Chain Reaction Control, Not Assay Specific
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type
Internal control that can be used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.