FDA 510(k)

CARDIAC CARE Q/C TEST KIT

K-Number: K782033 · 1978-12-15

Decision Date1978-12-15

Product CodeDRL

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CARDIAC CARE Q/C TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1978-12-15 under 510(k) number K782033. The device is classified under product code DRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC CARE Q/C TEST KIT?

CARDIAC CARE Q/C TEST KIT is a medical device that received FDA 510(k) clearance on 1978-12-15. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K782033.

When did CARDIAC CARE Q/C TEST KIT receive FDA 510(k) clearance?

CARDIAC CARE Q/C TEST KIT received FDA 510(k) clearance on 1978-12-15, under 510(k) number K782033.

Who is the listed applicant for CARDIAC CARE Q/C TEST KIT?

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

What is the FDA product code for CARDIAC CARE Q/C TEST KIT?

The FDA product code for CARDIAC CARE Q/C TEST KIT is DRL.

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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.