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FDA 510(k)

AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U

K-Number: K982831 · 1998-11-12

ApplicantOraSure Technologies, Inc.
Decision Date1998-11-12
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U 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 1998-11-12 under 510(k) number K982831. 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 AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U?

AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U is a medical device that received FDA 510(k) clearance on 1998-11-12. The listed applicant is OraSure Technologies, Inc.. The 510(k) number is K982831.

When did AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U receive FDA 510(k) clearance?

AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U received FDA 510(k) clearance on 1998-11-12, under 510(k) number K982831.

Who is the listed applicant for AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U?

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 AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U?

The FDA product code for AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U 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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