DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING
FDA 510(k) clearance K971905 · decided 1997-12-12
Clearance details
- K-number
- K971905
- Device name
- DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING
- Applicant
- Dako Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-23
- Decision date
- 1997-12-12
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- DEH
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Carpinteria, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.