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FDA 510(k)

CRE BUFFER CRE DYE

K-Number: K851993 · 1985-05-30

ApplicantAlpkem Corp.
Decision Date1985-05-30
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CRE BUFFER CRE DYE is the device name listed in this FDA 510(k) record. The listed applicant is Alpkem Corp.. It received FDA 510(k) clearance on 1985-05-30 under 510(k) number K851993. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRE BUFFER CRE DYE?

CRE BUFFER CRE DYE is a medical device that received FDA 510(k) clearance on 1985-05-30. The listed applicant is Alpkem Corp.. The 510(k) number is K851993.

When did CRE BUFFER CRE DYE receive FDA 510(k) clearance?

CRE BUFFER CRE DYE received FDA 510(k) clearance on 1985-05-30, under 510(k) number K851993.

Who is the listed applicant for CRE BUFFER CRE DYE?

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

What is the FDA product code for CRE BUFFER CRE DYE?

The FDA product code for CRE BUFFER CRE DYE is CGX.

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Other records listing Alpkem Corp. as applicant

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Related Devices (Code: CGX)

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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