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FDA 510(k)

EZ-SCREEN: CANNABINOID

K-Number: K862916 · 1987-01-07

ApplicantEnvironmental Diagnostics, Inc.
Decision Date1987-01-07
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EZ-SCREEN: CANNABINOID is the device name listed in this FDA 510(k) record. The listed applicant is Environmental Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-01-07 under 510(k) number K862916. The device is classified under product code KLT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-SCREEN: CANNABINOID?

EZ-SCREEN: CANNABINOID is a medical device that received FDA 510(k) clearance on 1987-01-07. The listed applicant is Environmental Diagnostics, Inc.. The 510(k) number is K862916.

When did EZ-SCREEN: CANNABINOID receive FDA 510(k) clearance?

EZ-SCREEN: CANNABINOID received FDA 510(k) clearance on 1987-01-07, under 510(k) number K862916.

Who is the listed applicant for EZ-SCREEN: CANNABINOID?

The FDA 510(k) record lists Environmental Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZ-SCREEN: CANNABINOID?

The FDA product code for EZ-SCREEN: CANNABINOID is KLT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Environmental Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K905700EZ-SCREEN: AMPHETAMINESK905057EZ-SCREEN:BARBITURATESK902681EZ-SCREEN:HCGK900203EZ-SCREEN:OPIATESK883105EZ-SCREEN CANNABINOID/COCAINE

Related Devices (Code: KLT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123518ABBOTT CARBAMAZEPINE ASSAYMicrogenics CorporationK103627ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORSAbbott LaboratoriesK063131CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLSThermo Electron OYK042808ADVIA IMS CARBAMAZEPINE METHODBayer Healthcare, LLCK031902ONLINE TDM CARBAMAZEPINERoche Diagnostics Corp.K011648RANDOX CARBAMAZEPINERandox Laboratories, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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