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FDA 510(k)

OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I

K-Number: K013882 · 2002-04-17

ApplicantOraSure Technologies, Inc.
Decision Date2002-04-17
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I 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 2002-04-17 under 510(k) number K013882. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I?

OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I is a medical device that received FDA 510(k) clearance on 2002-04-17. The listed applicant is OraSure Technologies, Inc.. The 510(k) number is K013882.

When did OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I receive FDA 510(k) clearance?

OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I received FDA 510(k) clearance on 2002-04-17, under 510(k) number K013882.

Who is the listed applicant for OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I?

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 OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I?

The FDA product code for OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I is JXM.

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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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