510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041408Substantially Equivalent

Polymedco Oc Auto Micro 80 Fob Test

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

K041408 is the FDA 510(k) clearance record for POLYMEDCO OC AUTO MICRO 80 FOB TEST, a class II device, cleared for Polymedco, Inc. on under FDA product code OOX (Automated Occult Blood Analyzer). FDA's definition for product code OOX reads: "The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding". FDA records list 19 510(k) clearances for POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC., from to . As of , FDA records show no recalls naming K041408.

Clearance record

Decision date
Received
(147 days to decision)
Product code
OOX Automated Occult Blood Analyzer
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
Polymedco, Inc. 510 Furnace Dock Rd., Cortlandt Manor NY
510(k) summary
Statement
Third party review
No

Clearances, product code OOX

Trailing 12 months

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

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