510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K941041Substantially Equivalent

Solor Care Technologies Corporation Opiates

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

K941041 is the FDA 510(k) clearance record for SOLOR CARE TECHNOLOGIES CORPORATION OPIATES, a class II device, cleared for Solar Technologies Corp. on under FDA product code DJG (Enzyme Immunoassay, Opiates). FDA records list one 510(k) clearance for Solar Technologies Corp. As of , FDA records show no recalls naming K941041.

Clearance record

Decision date
Received
(240 days to decision)
Product code
DJG Enzyme Immunoassay, Opiates
Regulation
21 CFR 862.3650
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Solar Technologies Corp. 1745 Eaton Ave., Bethlehem PA
510(k) summary
Statement
Third party review
No

Clearances, product code DJG

Trailing 12 months
3 clearances under product code DJG in the twelve months to October 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DJG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20263
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260