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FDA 510(k)

KULTSURE (CATALOGUE NO. M200)

K-Number: K860655 · 1986-03-06

ApplicantNcs Diagnostics, Inc.
Decision Date1986-03-06
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

KULTSURE (CATALOGUE NO. M200) is the device name listed in this FDA 510(k) record. The listed applicant is Ncs Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-03-06 under 510(k) number K860655. 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 KULTSURE (CATALOGUE NO. M200)?

KULTSURE (CATALOGUE NO. M200) is a medical device that received FDA 510(k) clearance on 1986-03-06. The listed applicant is Ncs Diagnostics, Inc.. The 510(k) number is K860655.

When did KULTSURE (CATALOGUE NO. M200) receive FDA 510(k) clearance?

KULTSURE (CATALOGUE NO. M200) received FDA 510(k) clearance on 1986-03-06, under 510(k) number K860655.

Who is the listed applicant for KULTSURE (CATALOGUE NO. M200)?

The FDA 510(k) record lists Ncs Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KULTSURE (CATALOGUE NO. M200)?

The FDA product code for KULTSURE (CATALOGUE NO. M200) is LIO.

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Other records listing Ncs Diagnostics, 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.

K943499KULTSURE STARSWAB(M240), MODIFICATIONK943498KULTSURE STARSWAB (M210), MODIFICATIONK882811STREPSLIDEK881209ASO SLIDE TESTK874019STAPHSLIDEK871404KULTSURE

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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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