510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882686Substantially Equivalent

Erythropoietin Enzyme Immunoassay

Amgen, Inc., Thousand Oaks CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882686 is the FDA 510(k) clearance record for ERYTHROPOIETIN ENZYME IMMUNOASSAY, a class II device, cleared for Amgen, Inc. on under FDA product code GGT (Assay, Erythropoietin). FDA records list 2 510(k) clearances for Amgen, Inc., from to . As of , FDA records show no recalls naming K882686.

Clearance record

Decision date
Received
(173 days to decision)
Product code
GGT Assay, Erythropoietin
Regulation
21 CFR 864.7250
Device class
Class II
Review panel
Hematology
Applicant
Amgen, Inc. 1840 De Havilland, Thousand Oaks CA
Third party review
No

Clearances, product code GGT

Trailing 12 months

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

FDA records show no clearances under product code GGT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GGT, 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