FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENTANA CEA PRIMARY ANTIBODY
K Number: K940242
·
Decision Dec 23, 1996
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
48
Review Days
1069
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Basic Information
- Device Name
- VENTANA CEA PRIMARY ANTIBODY
- K Number
- K940242
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ventana Medical Systems, Inc.
- Date Received
- January 19, 1994
- Decision Date
- December 23, 1996
- Product Code
- DFD
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DFD | Kappa, Peroxidase, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DFD), ordered by most recent decision date.
PSA ANTIBODY KIT
FDA 510(k)
FDA Class 2
·Immunology
PAP ANTIBODY KIT
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Ventana Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K242783 | Roche Digital Pathology Dx | Dec 17, 2024 | Substantially Equivalent |
| DEN240025 | VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) | Dec 5, 2024 | Unknown |
| K232879 | Roche Digital Pathology Dx (VENTANA DP 200) | Jun 14, 2024 | Substantially Equivalent |
| K212176 | CINtec Histology | Dec 10, 2021 | Substantially Equivalent |
| K172471 | VENTANA CD30 (Ber-H2) RxDx Assay | May 8, 2018 | Substantially Equivalent |
| DEN160019 | CINtec Histology (50 tests), CINtec Histology (250 tests) | Mar 4, 2017 | Unknown |
| K142965 | Virtuoso System for IHC PR (1E2) using iScan HT | Jul 16, 2015 | Substantially Equivalent |
| K140465 | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER | Mar 20, 2014 | Substantially Equivalent |
| K130515 | VIRTUOSO SYSTEM FOR IHC ER (SPI) | Nov 22, 2013 | Substantially Equivalent |
| K121516 | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) | Sep 26, 2013 | Substantially Equivalent |