510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081286Substantially Equivalent

Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone Sp1, Model M3634

Agilent Technologies, Inc., Carpinteria CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081286 is the FDA 510(k) clearance record for MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634, a class II device, cleared for Dako North America, Inc. on under FDA product code MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor). FDA records list 51 510(k) clearances for Agilent Technologies, Inc., from to . As of , FDA records show no recalls naming K081286.

Clearance record

Decision date
Received
(366 days to decision)
Product code
MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Dako North America, Inc. 6392 Via Real, Carpinteria CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MYA

Trailing 12 months

FDA records hold no clearances under product code MYA in the trailing twelve months.

FDA records show no clearances under product code MYA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MYA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260