510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921140Substantially Equivalent

Stc Diagnostics Auto0lyte Cocaine Metabolite Eia

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

K921140 is the FDA 510(k) clearance record for STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA, a class II device, cleared for Solarcare Technologies Corp,Inc. on under FDA product code JXO (Enzyme Immunoassay, Cocaine). FDA records list 28 510(k) clearances for Solarcare Technologies Corp,Inc., from to . As of , FDA records show no recalls naming K921140.

Clearance record

Decision date
Received
(163 days to decision)
Product code
JXO Enzyme Immunoassay, Cocaine
Regulation
21 CFR 862.3250
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Solarcare Technologies Corp,Inc. Ben Franklin Technology Center, Bethlehem PA
510(k) summary
Statement
Third party review
No

Clearances, product code JXO

Trailing 12 months

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

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