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FDA 510(k)

KULTSURE

K-Number: K871404 · 1987-04-21

ApplicantNcs Diagnostics, Inc.
Decision Date1987-04-21
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

KULTSURE 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 1987-04-21 under 510(k) number K871404. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KULTSURE?

KULTSURE is a medical device that received FDA 510(k) clearance on 1987-04-21. The listed applicant is Ncs Diagnostics, Inc.. The 510(k) number is K871404.

When did KULTSURE receive FDA 510(k) clearance?

KULTSURE received FDA 510(k) clearance on 1987-04-21, under 510(k) number K871404.

Who is the listed applicant for KULTSURE?

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?

The FDA product code for KULTSURE is JSM.

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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 TESTK874019STAPHSLIDEK870231KULTSURE

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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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