Submission Details
| 510(k) Number | K183100 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 07, 2018 |
| Decision Date | December 07, 2018 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Pathology (PA) |
| Summary | Statement |
Cleared
Special
Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
Dec 2018
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K183100 is an FDA 510(k) clearance for the Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra, a Immunohistochemistry Antibody Assay, Estrogen Receptor (Class II — Special Controls, product code MYA), submitted by Leica Biosystems Newcastle, Limited (Newcastle Upon Tyne, GB). The FDA issued a Cleared decision on December 7, 2018, 30 days after receiving the submission on November 7, 2018. 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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