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FDA 510(k)

CHEMLYTE

K-Number: K834395 · 1984-04-20

ApplicantDiachem Laboratories
Decision Date1984-04-20
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CHEMLYTE is the device name listed in this FDA 510(k) record. The listed applicant is Diachem Laboratories. It received FDA 510(k) clearance on 1984-04-20 under 510(k) number K834395. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMLYTE?

CHEMLYTE is a medical device that received FDA 510(k) clearance on 1984-04-20. The listed applicant is Diachem Laboratories. The 510(k) number is K834395.

When did CHEMLYTE receive FDA 510(k) clearance?

CHEMLYTE received FDA 510(k) clearance on 1984-04-20, under 510(k) number K834395.

Who is the listed applicant for CHEMLYTE?

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

What is the FDA product code for CHEMLYTE?

The FDA product code for CHEMLYTE is FKQ.

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Related Devices (Code: FKQ)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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