FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
K Number: K100015
·
Decision Aug 9, 2011
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
17
Review Days
582
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Basic Information
- Device Name
- VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
- K Number
- K100015
- 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
- January 4, 2010
- Decision Date
- August 9, 2011
- Product Code
- OVQ
- 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 |
|---|---|---|---|
| OVQ | Chronic Lymphocytic Leukemia Fish Probe Kit | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OVQ), ordered by most recent decision date.
View allOther Clearances by Abbott Molecular, Inc.
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| K233349 | Alinity m HSV 1 & 2 / VZV | May 3, 2024 | Substantially Equivalent |
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| 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 |
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