510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831365Substantially Equivalent

Testcorp Ana

Catheter Technology Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831365 is the FDA 510(k) clearance record for TESTCORP ANA, a class I device, cleared for Catheter Technology Corp. on under FDA product code LKS (Device, Parasite Concentration). FDA records list 13 510(k) clearances for Catheter Technology Corp., from to . As of , FDA records show no recalls naming K831365.

Clearance record

Decision date
Received
(37 days to decision)
Product code
LKS Device, Parasite Concentration
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Catheter Technology Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LKS

Trailing 12 months

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

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