510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941129Substantially Equivalent

Con-Kit

Medical Chemical Corporation, Santa Monica CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941129 is the FDA 510(k) clearance record for CON-KIT, a class I device, cleared for Medical Chemical Corp. on under FDA product code LKS (Device, Parasite Concentration). FDA records list 3 510(k) clearances for Medical Chemical Corp., from to . As of , FDA records show no recalls naming K941129.

Clearance record

Decision date
Received
(61 days to decision)
Product code
LKS Device, Parasite Concentration
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Medical Chemical Corp. 1909 Centinela Ave., Santa Monica CA
510(k) summary
Statement
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