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FDA 510(k)

LABONE MICRO-PLATE COTININE EIA

K-Number: K033601 · 2004-02-10

ApplicantLabone, Inc.
Decision Date2004-02-10
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LABONE MICRO-PLATE COTININE EIA is the device name listed in this FDA 510(k) record. The listed applicant is Labone, Inc.. It received FDA 510(k) clearance on 2004-02-10 under 510(k) number K033601. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABONE MICRO-PLATE COTININE EIA?

LABONE MICRO-PLATE COTININE EIA is a medical device that received FDA 510(k) clearance on 2004-02-10. The listed applicant is Labone, Inc.. The 510(k) number is K033601.

When did LABONE MICRO-PLATE COTININE EIA receive FDA 510(k) clearance?

LABONE MICRO-PLATE COTININE EIA received FDA 510(k) clearance on 2004-02-10, under 510(k) number K033601.

Who is the listed applicant for LABONE MICRO-PLATE COTININE EIA?

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

What is the FDA product code for LABONE MICRO-PLATE COTININE EIA?

The FDA product code for LABONE MICRO-PLATE COTININE EIA is DLJ.

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Other records listing Labone, 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.

K040198LABONE COCAINE METABOLITE MICRO-PLATE EIA

Related Devices (Code: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)Dade Behring, Inc.

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.

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