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Hycor Accupinch Thc Test

FDA 510(k)

Class II (US FDA 510(k))

510(k) K901334

by Hycor Biomedical, Inc.

Identifiers

510(k) Number
K901334 FDA 510(k)
FDA Product Code
LDJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3870 FDA 510(k)
Regulation Number
862.3870 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Hycor Accupinch Thc Test is an enzyme immunoassay for cannabinoids. It is a device used for in vitro diagnostic testing.

The device is supplied by Hycor Biomedical, Inc. and has been authorized with an FDA 510K clearance, specifically K901334. The device is classified under product code LDJ and regulation number 862.3870.

Frequently asked questions

What is the Hycor Accupinch Thc Test used for?

The Hycor Accupinch Thc Test is used for in vitro diagnostic testing of cannabinoids.

What type of device is the Hycor Accupinch Thc Test?

The Hycor Accupinch Thc Test is an enzyme immunoassay device.

Is the Hycor Accupinch Thc Test authorized by the FDA?

Yes, the Hycor Accupinch Thc Test has been authorized with an FDA 510K clearance, specifically K901334.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HYCOR ACCUPINCH THC TEST 510 (k) K901334 - FDA.report, HYCOR ACCUPINCH MORPHINE TEST (K900173) — FDA 510(k) | Innolitics, HYCOR ACCUPINCH MORPHINE TEST 510 (k) K900173 - FDA.report, Hycor Biomedical, Inc. FDA 510 (k) Products (1989-2008)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hycor Biomedical, Inc.

Sources (1)

  • FDA 510(k) K901334 24 fields · synced Oct 1, 2026