510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K861452Substantially Equivalent

Monostar System: Im Latex Test

U.S. Health Resources Corp., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861452 is the FDA 510(k) clearance record for MONOSTAR SYSTEM: IM LATEX TEST, a class II device, cleared for U.S. Health Resources Corp. on under FDA product code KTN (System, Test, Infectious Mononucleosis). FDA records list 2 510(k) clearances for U.S. Health Resources Corp., from to . As of , FDA records show no recalls naming K861452.

Clearance record

Decision date
Received
(25 days to decision)
Product code
KTN System, Test, Infectious Mononucleosis
Regulation
21 CFR 866.5640
Device class
Class II
Review panel
Immunology
Applicant
U.S. Health Resources Corp. 16101 N. W. 57th. Ave., Miami FL
Third party review
No

Clearances, product code KTN

Trailing 12 months

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

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