FDA 510(k)

CK-B RIA KIT

K-Number: K840549 · 1984-05-07

ApplicantDiagnostic Systems Laboratories, Inc.

Decision Date1984-05-07

Product CodeJHX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CK-B RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1984-05-07 under 510(k) number K840549. The device is classified under product code JHX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CK-B RIA KIT?

CK-B RIA KIT is a medical device that received FDA 510(k) clearance on 1984-05-07. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K840549.

When did CK-B RIA KIT receive FDA 510(k) clearance?

CK-B RIA KIT received FDA 510(k) clearance on 1984-05-07, under 510(k) number K840549.

Who is the listed applicant for CK-B RIA KIT?

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

What is the FDA product code for CK-B RIA KIT?

The FDA product code for CK-B RIA KIT is JHX.

Other records listing Diagnostic Systems Laboratories, Inc. as applicant

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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.