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FDA 510(k)

MICROGENICS THC CONTROL SETS

K-Number: K943048 · 1994-08-24

ApplicantMicrogenics Corp.
Decision Date1994-08-24
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MICROGENICS THC CONTROL SETS is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 1994-08-24 under 510(k) number K943048. 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 MICROGENICS THC CONTROL SETS?

MICROGENICS THC CONTROL SETS is a medical device that received FDA 510(k) clearance on 1994-08-24. The listed applicant is Microgenics Corp.. The 510(k) number is K943048.

When did MICROGENICS THC CONTROL SETS receive FDA 510(k) clearance?

MICROGENICS THC CONTROL SETS received FDA 510(k) clearance on 1994-08-24, under 510(k) number K943048.

Who is the listed applicant for MICROGENICS THC CONTROL SETS?

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

What is the FDA product code for MICROGENICS THC CONTROL SETS?

The FDA product code for MICROGENICS THC CONTROL SETS is LAS.

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Other records listing Microgenics Corp. as applicant

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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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