510(k) K100015
- Device
- VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
- Applicant
- ABBOTT MOLECULAR, INC.
- 510(k) number
- K100015
- Product code
- OVQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-08-09
- Date received
- 2010-01-04
- Regulation
- 866.6040
- Classification name
- Chronic Lymphocytic Leukemia Fish Probe Kit
- Medical specialty
- Immunology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAMELA L SWATKOWSKI
- Address
- 1300 E Touhy Ave. Des Plaines IL US 60018 60018
FDA Registration Numbers#
- 3005248192
Source Documents#
Other 510(k) Records For Product Code OVQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962873 | CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE | Vysis | 1997-01-13 |
Legacy Summary#
summary
FDA Review#
Decision Summary