FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020
K Number: K091960
·
Decision Aug 29, 2011
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
17
Review Days
789
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Basic Information
- Device Name
- VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020
- K Number
- K091960
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6040
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Molecular, Inc.
- Date Received
- July 1, 2009
- Decision Date
- August 29, 2011
- Product Code
- OWK
- Advisory Committee
- Immunology
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OWK | Early Growth Response 1 (Egr) Fish Probe Kit | FDA class 2 | Immunology |
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| K222379 | Alinity m STI Assay | Mar 3, 2023 | Substantially Equivalent |
| K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) | Jul 15, 2022 | Substantially Equivalent |
| K202977 | Alinity m STI Assay | Apr 29, 2022 | Substantially Equivalent |
| K140354 | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG | May 9, 2014 | Substantially Equivalent |