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FDA 510(k)

TRANSYSTEM AMIES WITH CHARCOAL

K-Number: K924330 · 1992-12-24

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

Device Summary

TRANSYSTEM AMIES WITH 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 K924330. 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 WITH CHARCOAL?

TRANSYSTEM AMIES WITH 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 K924330.

When did TRANSYSTEM AMIES WITH CHARCOAL receive FDA 510(k) clearance?

TRANSYSTEM AMIES WITH CHARCOAL received FDA 510(k) clearance on 1992-12-24, under 510(k) number K924330.

Who is the listed applicant for TRANSYSTEM AMIES WITH 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 WITH CHARCOAL?

The FDA product code for TRANSYSTEM AMIES WITH CHARCOAL is LIO.

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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 MEDIUMK924329TRANSYSTEM AMIES W/O 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

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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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