510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970100Substantially Equivalent

Tech Simple Syphilis Positive Serum Control Monitor Ontrak Syphilis Positive Serum Control

Simplicity Diagnostics, Inc., Hatboro PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970100 is the FDA 510(k) clearance record for TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL, a class I device, cleared for Simplicity Diagnostics, Inc. on under FDA product code MJX (Kit, Serological, Positive Control). FDA records list 5 510(k) clearances for Simplicity Diagnostics, Inc., from to . As of , FDA records show no recalls naming K970100.

Clearance record

Decision date
Received
(59 days to decision)
Product code
MJX Kit, Serological, Positive Control
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Simplicity Diagnostics, Inc. 31 N. York Rd., Hatboro PA
510(k) summary
Statement
Third party review
No

Clearances, product code MJX

Trailing 12 months

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

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