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FDA 510(k)

ALKALINE BUFFER

K-Number: K791688 · 1979-09-17

ApplicantHi Chem, Inc.
Decision Date1979-09-17
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE BUFFER is the device name listed in this FDA 510(k) record. The listed applicant is Hi Chem, Inc.. It received FDA 510(k) clearance on 1979-09-17 under 510(k) number K791688. 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 ALKALINE BUFFER?

ALKALINE BUFFER is a medical device that received FDA 510(k) clearance on 1979-09-17. The listed applicant is Hi Chem, Inc.. The 510(k) number is K791688.

When did ALKALINE BUFFER receive FDA 510(k) clearance?

ALKALINE BUFFER received FDA 510(k) clearance on 1979-09-17, under 510(k) number K791688.

Who is the listed applicant for ALKALINE BUFFER?

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

What is the FDA product code for ALKALINE BUFFER?

The FDA product code for ALKALINE BUFFER is CGX.

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Other records listing Hi Chem, Inc. 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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