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FDA 510(k)

MAPROTILINE

K-Number: K831735 · 1983-07-26

ApplicantUtak Laboratories, Inc.
Decision Date1983-07-26
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MAPROTILINE is the device name listed in this FDA 510(k) record. The listed applicant is Utak Laboratories, Inc.. It received FDA 510(k) clearance on 1983-07-26 under 510(k) number K831735. The device is classified under product code LAS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAPROTILINE?

MAPROTILINE is a medical device that received FDA 510(k) clearance on 1983-07-26. The listed applicant is Utak Laboratories, Inc.. The 510(k) number is K831735.

When did MAPROTILINE receive FDA 510(k) clearance?

MAPROTILINE received FDA 510(k) clearance on 1983-07-26, under 510(k) number K831735.

Who is the listed applicant for MAPROTILINE?

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

What is the FDA product code for MAPROTILINE?

The FDA product code for MAPROTILINE is LAS.

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Other records listing Utak Laboratories, 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.

K903061UTAK LABORATORIES TOXICOLOGY CONTROLK883147TRACE ELEMENTS SERUM TOXICOLOGY CONTROLK862418BENZODIAZEPINES TOXICOLOGY CONTROLK862419SERUM VANCOMYCIN TOXICOLOGY CONTROLK862421SERUM CLONAZEPAM TOXICOLOGY CONTROLK862420UTAK-STABBS TOXICOLOGY CONTROL

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Related Devices (Code: LAS)

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.

K080459CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLSChromsystems Instruments & Chemicals GmbHK072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELMore DiagnosticsK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLQuantimetrix Corp.K051074MAS IMMUNOSUPPRESSANT CONTROLSMicrogenics Corp.K040411DRI OXYCODONE ASSAYMicrogenics Corp.K032842MICROGENICS CYCLOSPORINE CONTROL KITMicrogenics Corp.

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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