510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924061Substantially Equivalent

Cancer Antigen Control

Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC, Cortlandt Manor NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924061 is the FDA 510(k) clearance record for CANCER ANTIGEN CONTROL, a class I device, cleared for Polymedco, Inc. on under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)). FDA records list 19 510(k) clearances for POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC., from to . As of , FDA records show one recall naming K924061.

Clearance record

Decision date
Received
(195 days to decision)
Product code
JJY Multi-Analyte Controls, All Kinds (Assayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Polymedco, Inc. 510 Furnace Dock Rd., Cortlandt Manor NY
510(k) summary
Statement
Third party review
No

Clearances, product code JJY

Trailing 12 months

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

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