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FDA 510(k)

KULTSURE STARSWAB (M210), MODIFICATION

K-Number: K943498 · 1994-11-30

ApplicantNcs Diagnostics, Inc.
Decision Date1994-11-30
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

KULTSURE STARSWAB (M210), MODIFICATION 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 1994-11-30 under 510(k) number K943498. 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 STARSWAB (M210), MODIFICATION?

KULTSURE STARSWAB (M210), MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-11-30. The listed applicant is Ncs Diagnostics, Inc.. The 510(k) number is K943498.

When did KULTSURE STARSWAB (M210), MODIFICATION receive FDA 510(k) clearance?

KULTSURE STARSWAB (M210), MODIFICATION received FDA 510(k) clearance on 1994-11-30, under 510(k) number K943498.

Who is the listed applicant for KULTSURE STARSWAB (M210), MODIFICATION?

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 STARSWAB (M210), MODIFICATION?

The FDA product code for KULTSURE STARSWAB (M210), MODIFICATION 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), MODIFICATIONK882811STREPSLIDEK881209ASO SLIDE TESTK874019STAPHSLIDEK871404KULTSUREK870231KULTSURE

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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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