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FDA 510(k)

MODIFICATION MICROTRAK DIRECT SPECIMEN TEST

K-Number: K843935 · 1984-10-23

ApplicantSyva Co.
Decision Date1984-10-23
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFICATION MICROTRAK DIRECT SPECIMEN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1984-10-23 under 510(k) number K843935. The device is classified under product code LIO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION MICROTRAK DIRECT SPECIMEN TEST?

MODIFICATION MICROTRAK DIRECT SPECIMEN TEST is a medical device that received FDA 510(k) clearance on 1984-10-23. The listed applicant is Syva Co.. The 510(k) number is K843935.

When did MODIFICATION MICROTRAK DIRECT SPECIMEN TEST receive FDA 510(k) clearance?

MODIFICATION MICROTRAK DIRECT SPECIMEN TEST received FDA 510(k) clearance on 1984-10-23, under 510(k) number K843935.

Who is the listed applicant for MODIFICATION MICROTRAK DIRECT SPECIMEN TEST?

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

What is the FDA product code for MODIFICATION MICROTRAK DIRECT SPECIMEN TEST?

The FDA product code for MODIFICATION MICROTRAK DIRECT SPECIMEN TEST is LIO.

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Related Devices (Code: LIO)

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.

K222613ARX Liquid Amies Collection & Transport SystemArx Sciences, Inc.K131630PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEMPuritan Medical Products, LLCK120846TRANSPORT CULTURE MEDIUM DEVICEPuritan Medical Products, LLCK103805MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICEMedical Wire & Equipment Company (Bath), Ltd.K082472VIROCULT, MODEL MW950Medical Wire & Equipment Company (Bath), Ltd.K070062COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USEDiesse Diagnostica Senese S.P.A.

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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