510(k) DEN130010
- Device
- VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
- Applicant
- Abbott Molecular, Inc.
- 510(k) number
- DEN130010
- Product code
- PDO
- Decision
- Unknown (DENG)
- Decision date
- 2013-07-29
- Date received
- 2013-04-09
- Regulation
- 864.1870
- Classification name
- Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- NANCY W BENGTSON
- Address
- 1300 E Touhy Ave. Des Plaines IL US 60018 60018
FDA Registration Numbers#
- 3019837962
- 3005248192
Source Documents#
510(k) summary PDF not indicated by FDA