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FDA 510(k)

KDI QUIK TEST(TM) MARIJUANA SCREEN

K-Number: K870197 · 1987-06-01

ApplicantKeystone Diagnostics, Inc.
Decision Date1987-06-01
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

KDI QUIK TEST(TM) MARIJUANA SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Keystone Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-06-01 under 510(k) number K870197. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KDI QUIK TEST(TM) MARIJUANA SCREEN?

KDI QUIK TEST(TM) MARIJUANA SCREEN is a medical device that received FDA 510(k) clearance on 1987-06-01. The listed applicant is Keystone Diagnostics, Inc.. The 510(k) number is K870197.

When did KDI QUIK TEST(TM) MARIJUANA SCREEN receive FDA 510(k) clearance?

KDI QUIK TEST(TM) MARIJUANA SCREEN received FDA 510(k) clearance on 1987-06-01, under 510(k) number K870197.

Who is the listed applicant for KDI QUIK TEST(TM) MARIJUANA SCREEN?

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

What is the FDA product code for KDI QUIK TEST(TM) MARIJUANA SCREEN?

The FDA product code for KDI QUIK TEST(TM) MARIJUANA SCREEN is LDJ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Keystone 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.

K875219MODIFICATION TO KDI QUIK TEST MARIJUANA SCREEN

Related Devices (Code: LDJ)

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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Official Source

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

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