510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962435Substantially Equivalent

Stc Auto-Lyte Urinary Glucose Assay

OraSure Technologies, Inc., Bethlehem PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962435 is the FDA 510(k) clearance record for STC AUTO-LYTE URINARY GLUCOSE ASSAY, a class II device, cleared for OraSure Technologies, Inc. on under FDA product code CFR (Hexokinase, Glucose). FDA records list 30 510(k) clearances for OraSure Technologies, Inc., from to . As of , FDA records show no recalls naming K962435.

Clearance record

Decision date
Received
(185 days to decision)
Product code
CFR Hexokinase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
OraSure Technologies, Inc. 1745 Eaton Ave., Bethlehem PA
510(k) summary
Statement
Third party review
No

Clearances, product code CFR

Trailing 12 months
1 clearance under product code CFR in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CFR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260