VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020— 510(k) K091960
Substantially EquivalentAbbott Molecular, Inc.
FDA 510(k) clearance K091960 for VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020, Substantially Equivalent on 2011-08-29. Applicant: Abbott Molecular, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Molecular, Inc.
- Product code
- Code OWK
- Device class
- Class 2
- Regulation
- 21 CFR 866.6040
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Des Plaines, IL, US
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