FDA 510(k)

STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I

K-Number: K002375 · 2001-01-26

Decision Date2001-01-26

Product CodeLDJ

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I is the device name listed in this FDA 510(k) record. The listed applicant is OraSure Technologies, Inc.. It received FDA 510(k) clearance on 2001-01-26 under 510(k) number K002375. 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 STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I?

STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I is a medical device that received FDA 510(k) clearance on 2001-01-26. The listed applicant is OraSure Technologies, Inc.. The 510(k) number is K002375.

When did STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I receive FDA 510(k) clearance?

STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I received FDA 510(k) clearance on 2001-01-26, under 510(k) number K002375.

Who is the listed applicant for STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I?

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

What is the FDA product code for STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I?

The FDA product code for STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I is LDJ.

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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.