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Solar Technologies Corp. Opiates

by Solar Technologies Corp.

510(k) K941041

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK941041 Date2 Nov 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Solor Care Technologies Corporation Opiates
510(k) Number
FDA Product Code
DJG
Device Class
Class II
Regulation
21 CFR Part 862.3650
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Solar Technologies Corp. Opiates is an enzyme immunoassay device used for the detection of opiates in clinical samples. This device is classified under product code DJG and is intended for use in clinical toxicology settings.

The device is supplied with registration numbers and has received FDA 510(k) clearance as substantially equivalent. It is manufactured by Solar Technologies Corp. and is regulated under number 862.3650. The device is not specified as single-use or reusable, and no information regarding MRI safety or sterility is provided in the data.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Solar Technologies Corp. Opiates device used for?

    The Solar Technologies Corp. Opiates is an enzyme immunoassay device specifically designed for the detection of opiates in clinical samples, intended for use in clinical toxicology settings to help identify opioid use or exposure.

  • Is the Solar Opiates device single-use or reusable?

    The device data does not specify whether the Solar Opiates device is single-use or reusable. This information would need to be obtained directly from the manufacturer or product documentation.

  • What regulatory approvals does the Solar Opiates device have?

    The Solar Technologies Corp. Opiates device has received FDA 510(k) clearance as substantially equivalent, with product code DJG and regulation number 862.3650. It is classified under device class 2 and is intended for clinical toxicology applications.

  • What information is provided about the device's sterility?

    The device data does not contain any information regarding the sterility of the Solar Technologies Corp. Opiates device. This specification would need to be confirmed through the manufacturer's documentation or direct inquiry.