510(k) K083430
- Device
- REAL-TIME PCR INTERNAL CONTROL 2B SET
- Applicant
- NANOGEN, INC.
- 510(k) number
- K083430
- Product code
- OLD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-01-15
- Date received
- 2008-11-19
- Regulation
- 862.1660
- Classification name
- Internal Polymerase Chain Reaction Control, Not Assay Specific
- Medical specialty
- Clinical Chemistry
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- E. JOSEPH MCMULLEN
- Address
- 10398 Pacific Center Ct. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3003540236
- 2023365
- 3007799234
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
Decision Summary