510(k) K962873
- Device
- CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
- Applicant
- VYSIS
- 510(k) number
- K962873
- Product code
- OVQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-01-13
- Date received
- 1996-07-23
- 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
- RUSSEL K ENNS
- Address
- 3100 Woodcreek Dr. Downers Grove IL US 60515 60515
FDA Registration Numbers#
- 3005248192
Source Documents#
Other 510(k) Records For Product Code OVQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100015 | VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 | Abbott Molecular, Inc. | 2011-08-09 |
Legacy Summary#
summary
FDA Review#
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