Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal Antibody for Immunoenzymatic Staining
FDA 510(k) K971905 · Dako Corp.
510(k) numberK971905
Submission
- Device name
- Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal Antibody for Immunoenzymatic Staining
- Applicant
- Dako Corp.
Carpinteria, CA, US - Received
- May 23, 1997
- Decision date
- December 12, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DEH – Lambda, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
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Questions and answers
When was Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal Antibody for Immunoenzymatic Staining cleared by the FDA?
Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal Antibody for Immunoenzymatic Staining (K971905) received a 510(k) decision of Substantially Equivalent on December 12, 1997, 203 days after the submission was received.
What is the product code of K971905?
The FDA product code is DEH – Lambda, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.