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FDA 510(k)

AUTO-LYTE COTININE EIA

K-Number: K972481 · 1997-10-21

ApplicantOraSure Technologies, Inc.
Decision Date1997-10-21
Product CodeMKU
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AUTO-LYTE COTININE EIA 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 1997-10-21 under 510(k) number K972481. The device is classified under product code MKU. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO-LYTE COTININE EIA?

AUTO-LYTE COTININE EIA is a medical device that received FDA 510(k) clearance on 1997-10-21. The listed applicant is OraSure Technologies, Inc.. The 510(k) number is K972481.

When did AUTO-LYTE COTININE EIA receive FDA 510(k) clearance?

AUTO-LYTE COTININE EIA received FDA 510(k) clearance on 1997-10-21, under 510(k) number K972481.

Who is the listed applicant for AUTO-LYTE COTININE EIA?

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 COTININE EIA?

The FDA product code for AUTO-LYTE COTININE EIA is MKU.

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Other records listing OraSure Technologies, 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.

K060859COMPOUND W FREEZE OFF WART REMOVAL SYSTEMK023487HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAMEK013882OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110IK020371UPLINK TEST SYSTEMK011057INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXXK002375STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I

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Related Devices (Code: MKU)

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.

K192517Psychemedics Microplate EIA for Cotinine in HairPsychemedics CorporationK192299LZI Cotinine II Enzyme ImmunoassayLin-Zhi International, Inc.K062565STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINEPrinceton BioMeditech Corp.K021944COZART EIA COTININE URINE KITCozart Bioscience , Ltd.K974534MICRO-PLATE COTININE EIAOraSure Technologies, Inc.K974234MICRO-PLATE COTININE EIAOraSure Technologies, Inc.

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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