FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHEMMATE LCA
K Number: K973393
·
Decision Sep 25, 1997
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
52
Applicant Total
48
Review Days
86
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Basic Information
- Device Name
- CHEMMATE LCA
- K Number
- K973393
- 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
- July 1, 1997
- Decision Date
- September 25, 1997
- Product Code
- DEH
- 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 |
|---|---|---|---|
| DEH | Lambda, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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| K212176 | CINtec Histology | Dec 10, 2021 | Substantially Equivalent |
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| 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 |
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