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FDA 510(k)

GASTRO-INTESTINAL ACCU-CULSHURE TM

K-Number: K903638 · 1991-01-18

ApplicantMedical Laboratory Automation Systems, Inc.
Decision Date1991-01-18
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GASTRO-INTESTINAL ACCU-CULSHURE TM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Laboratory Automation Systems, Inc.. It received FDA 510(k) clearance on 1991-01-18 under 510(k) number K903638. 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 GASTRO-INTESTINAL ACCU-CULSHURE TM?

GASTRO-INTESTINAL ACCU-CULSHURE TM is a medical device that received FDA 510(k) clearance on 1991-01-18. The listed applicant is Medical Laboratory Automation Systems, Inc.. The 510(k) number is K903638.

When did GASTRO-INTESTINAL ACCU-CULSHURE TM receive FDA 510(k) clearance?

GASTRO-INTESTINAL ACCU-CULSHURE TM received FDA 510(k) clearance on 1991-01-18, under 510(k) number K903638.

Who is the listed applicant for GASTRO-INTESTINAL ACCU-CULSHURE TM?

The FDA 510(k) record lists Medical Laboratory Automation Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GASTRO-INTESTINAL ACCU-CULSHURE TM?

The FDA product code for GASTRO-INTESTINAL ACCU-CULSHURE TM is LIO.

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Other records listing Medical Laboratory Automation Systems, 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.

K962664ELECTRA 1800C AUTOMATIC COAGULATION ANALYZERK944227ELECTRA 1400C AUTOMATIC COAGULATION ANALYZERK931206ELECTRA 1600C AUTOMATIC COAGULATION TIMERK923220THROMBIN CLOT TIME TEST PROCEDUREK903405CHLAMYDIA ACCU-CULSHURE TMK903406VIRAL ACCU-CULSHURE TM

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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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