510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935565Substantially Equivalent

Opiates Micro-Plate Assay

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

K935565 is the FDA 510(k) clearance record for OPIATES MICRO-PLATE ASSAY, a class II device, cleared for Solarcare Technologies Corp,Inc. on under FDA product code DJG (Enzyme Immunoassay, Opiates). FDA records list 28 510(k) clearances for Solarcare Technologies Corp,Inc., from to . As of , FDA records show no recalls naming K935565.

Clearance record

Decision date
Received
(603 days to decision)
Product code
DJG Enzyme Immunoassay, Opiates
Regulation
21 CFR 862.3650
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Solarcare Technologies Corp,Inc. 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