Submission Details
| 510(k) Number | K993957 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 22, 1999 |
| Decision Date | March 03, 2000 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
Cleared
Traditional
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
Mar 2000
Decision
102d
Days
Class 2
Risk
About This 510(k) Submission
K993957 is an FDA 510(k) clearance for the DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR, a Immunohistochemistry Antibody Assay, Estrogen Receptor (Class II — Special Controls, product code MYA), submitted by Dako Corp. (Carpinteria, US). The FDA issued a Cleared decision on March 3, 2000, 102 days after receiving the submission on November 22, 1999. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.
Device Classification
| Product Code | MYA — Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.1860 |
Manufacturer
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