CHEMMATE LCA
FDA 510(k) clearance K973393 · decided 1997-09-25
Clearance details
- K-number
- K973393
- Device name
- CHEMMATE LCA
- Applicant
- Ventana Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-01
- Decision date
- 1997-09-25
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- DEH
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S057) | Ventana Medical Systems, Inc. | 2025-06-20 |
| VENTANA ALK (D5F3) CDX ASSAY (P140025/S025) | Ventana Medical Systems, Inc. | 2025-06-20 |
| VENTANA PD-L1 (SP263) ASSAY (P160046/S020) | Ventana Medical Systems, Inc. | 2025-06-20 |