510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230090Unknown

First To Know Syphilis Test

Nowdiagnostics, Inc., Springdale AZ / Direct, Unknown
FDA source (opens on fda.gov)

DEN230090 is the FDA 510(k) clearance record for First To Know Syphilis Test, a class II device, cleared for Nowdiagnostics on under FDA product code SBZ (Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users). FDA's definition for product code SBZ reads: "Test for detection of antibodies associated with syphilis performed by lay users is an in vitro diagnostic device used for detection of antibodies in clinical specimens for use in home settings, or similar environments. The device is...". FDA records list one 510(k) clearance for Nowdiagnostics. As of , FDA records show no recalls naming DEN230090.

Clearance record

Decision date
Received
(233 days to decision)
Product code
SBZ Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
Regulation
21 CFR 866.3986
Device class
Class II
Review panel
Microbiology
Applicant
Nowdiagnostics 1200 Stewart Pl., Springdale AZ
Third party review
No

Clearances, product code SBZ

Trailing 12 months

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

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