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FDA 510(k)

SEROCLUSTER U AND V

K-Number: K800240 · 1980-02-13

ApplicantCorning Costar Corp.
Decision Date1980-02-13
Product CodeJTC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SEROCLUSTER U AND V is the device name listed in this FDA 510(k) record. The listed applicant is Corning Costar Corp.. It received FDA 510(k) clearance on 1980-02-13 under 510(k) number K800240. The device is classified under product code JTC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEROCLUSTER U AND V?

SEROCLUSTER U AND V is a medical device that received FDA 510(k) clearance on 1980-02-13. The listed applicant is Corning Costar Corp.. The 510(k) number is K800240.

When did SEROCLUSTER U AND V receive FDA 510(k) clearance?

SEROCLUSTER U AND V received FDA 510(k) clearance on 1980-02-13, under 510(k) number K800240.

Who is the listed applicant for SEROCLUSTER U AND V?

The FDA 510(k) record lists Corning Costar Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEROCLUSTER U AND V?

The FDA product code for SEROCLUSTER U AND V is JTC.

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Other records listing Corning Costar Corp. 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.

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Related Devices (Code: JTC)

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.

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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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