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FDA 510(k)

TRANSYSTEM AMIES W/O CHARCOAL

K-Number: K924329 · 1992-12-24

ApplicantPro-Lab Diagnostics
Decision Date1992-12-24
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TRANSYSTEM AMIES W/O CHARCOAL is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Lab Diagnostics. It received FDA 510(k) clearance on 1992-12-24 under 510(k) number K924329. 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 TRANSYSTEM AMIES W/O CHARCOAL?

TRANSYSTEM AMIES W/O CHARCOAL is a medical device that received FDA 510(k) clearance on 1992-12-24. The listed applicant is Pro-Lab Diagnostics. The 510(k) number is K924329.

When did TRANSYSTEM AMIES W/O CHARCOAL receive FDA 510(k) clearance?

TRANSYSTEM AMIES W/O CHARCOAL received FDA 510(k) clearance on 1992-12-24, under 510(k) number K924329.

Who is the listed applicant for TRANSYSTEM AMIES W/O CHARCOAL?

The FDA 510(k) record lists Pro-Lab Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSYSTEM AMIES W/O CHARCOAL?

The FDA product code for TRANSYSTEM AMIES W/O CHARCOAL is LIO.

Related Clinical Trials

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Other records listing Pro-Lab Diagnostics 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.

K944421E.COLI 0157 LATEX TESTK924331TRANSYSTEM LIQUID STUART MEDIUMK924328TRANSYSTEM LIQUID AMIES MEDIUMK924330TRANSYSTEM AMIES WITH CHARCOAL

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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