Submission Details
| 510(k) Number | K971905 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 23, 1997 |
| Decision Date | December 12, 1997 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING
Dec 1997
Decision
203d
Days
Class 2
Risk
About This 510(k) Submission
K971905 is an FDA 510(k) clearance for the DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING, a Lambda, Antigen, Antiserum, Control (Class II — Special Controls, product code DEH), submitted by Dako Corp. (Carpinteria, US). The FDA issued a Cleared decision on December 12, 1997, 203 days after receiving the submission on May 23, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.
Device Classification
| Product Code | DEH — Lambda, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5550 |
Manufacturer
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