FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CINtec Histology (50 tests), CINtec Histology (250 tests)
K Number: DEN160019
·
Decision Mar 4, 2017
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
48
Review Days
285
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Basic Information
- Device Name
- CINtec Histology (50 tests), CINtec Histology (250 tests)
- K Number
- DEN160019
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 864.1865
- Medical Specialty
- Pathology
- Decision
- Unknown
- Applicant
- Ventana Medical Systems, Inc.
- Date Received
- May 23, 2016
- Decision Date
- March 4, 2017
- Product Code
- PRB
- Advisory Committee
- Pathology
- 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 |
|---|---|---|---|
| PRB | Cervical Intraepithelial Neoplasia (Cin) Test System | FDA class 2 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PRB), ordered by most recent decision date.
View allOther 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 |
| 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 |
| K122143 | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER | Sep 19, 2013 | Substantially Equivalent |