510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN190031Unknown

NP Screen

Advance Sentry Corporation, Markham, CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN190031 is the FDA 510(k) clearance record for NP Screen, a class II device, cleared for Advance Sentry Corporation on under FDA product code OJY (Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers). FDA's definition for product code OJY reads: "A device to detect or measure nucleic acid from viruses associated with head and neck cancers is an in vitro diagnostic test for prescription use in the detection of viral nucleic acid in nasopharyngeal or oropharyngeal cellular specimens...". FDA records list one 510(k) clearance for Advance Sentry Corporation. As of , FDA records show no recalls naming DEN190031.

Clearance record

Decision date
Received
(322 days to decision)
Product code
OJY Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers
Regulation
21 CFR 866.3236
Device class
Class II
Review panel
Microbiology
Applicant
Advance Sentry Corporation 7155 Woodbine Ave., Suite 202, Markham, CA
Third party review
No

Clearances, product code OJY

Trailing 12 months

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

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