510(k) DEN130042
- Device
- MISEQDX UNIVERSAL KIT 1.0
- Applicant
- Illumina, Inc.
- 510(k) number
- DEN130042
- Product code
- PFT
- Decision
- Unknown (DENG)
- Decision date
- 2013-11-19
- Date received
- 2013-10-04
- Regulation
- 862.3800
- Classification name
- Reagents For Molecular Diagnostic Test Systems
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- LEANNE M KIVIHARJU
- Address
- 5200 Illumina Way San Diego CA US 92122 92122
FDA Registration Numbers#
- 3003335080
- 3003673482
- 3017201274
- 3003218906
- 3004613294
- 3007287152
- 3008682397
- 3015547437
- 3013508066
- 3009875001
- 2915274
- 3011805506
- 3007102730
Source Documents#
510(k) summary PDF not indicated by FDA