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FDA 510(k)

CANNABINOID EIA ASSAY

K-Number: K943998 · 1994-11-04

ApplicantDiagnostic Reagents, Inc.
Decision Date1994-11-04
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CANNABINOID EIA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1994-11-04 under 510(k) number K943998. 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 CANNABINOID EIA ASSAY?

CANNABINOID EIA ASSAY is a medical device that received FDA 510(k) clearance on 1994-11-04. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K943998.

When did CANNABINOID EIA ASSAY receive FDA 510(k) clearance?

CANNABINOID EIA ASSAY received FDA 510(k) clearance on 1994-11-04, under 510(k) number K943998.

Who is the listed applicant for CANNABINOID EIA ASSAY?

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

What is the FDA product code for CANNABINOID EIA ASSAY?

The FDA product code for CANNABINOID EIA ASSAY is LDJ.

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Other records listing Diagnostic Reagents, 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.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAY

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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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