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FDA 510(k)

HYDORRYBUTYRATE DEHYDROGENASE

K-Number: K780042 · 1978-02-01

ApplicantBeckman Instruments, Inc.
Decision Date1978-02-01
Product CodeJMK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HYDORRYBUTYRATE DEHYDROGENASE is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1978-02-01 under 510(k) number K780042. The device is classified under product code JMK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDORRYBUTYRATE DEHYDROGENASE?

HYDORRYBUTYRATE DEHYDROGENASE is a medical device that received FDA 510(k) clearance on 1978-02-01. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K780042.

When did HYDORRYBUTYRATE DEHYDROGENASE receive FDA 510(k) clearance?

HYDORRYBUTYRATE DEHYDROGENASE received FDA 510(k) clearance on 1978-02-01, under 510(k) number K780042.

Who is the listed applicant for HYDORRYBUTYRATE DEHYDROGENASE?

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

What is the FDA product code for HYDORRYBUTYRATE DEHYDROGENASE?

The FDA product code for HYDORRYBUTYRATE DEHYDROGENASE is JMK.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: JMK)

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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