FDA 510(k)

AGGLUTINOTEST-C-REACTIVE PROTEIN

K-Number: K791461 · 1979-12-31

Decision Date1979-12-31

Product CodeDCK

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

AGGLUTINOTEST-C-REACTIVE PROTEIN is the device name listed in this FDA 510(k) record. The listed applicant is Volu Sol Medical Industries. It received FDA 510(k) clearance on 1979-12-31 under 510(k) number K791461. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGGLUTINOTEST-C-REACTIVE PROTEIN?

AGGLUTINOTEST-C-REACTIVE PROTEIN is a medical device that received FDA 510(k) clearance on 1979-12-31. The listed applicant is Volu Sol Medical Industries. The 510(k) number is K791461.

When did AGGLUTINOTEST-C-REACTIVE PROTEIN receive FDA 510(k) clearance?

AGGLUTINOTEST-C-REACTIVE PROTEIN received FDA 510(k) clearance on 1979-12-31, under 510(k) number K791461.

Who is the listed applicant for AGGLUTINOTEST-C-REACTIVE PROTEIN?

The FDA 510(k) record lists Volu Sol Medical Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGGLUTINOTEST-C-REACTIVE PROTEIN?

The FDA product code for AGGLUTINOTEST-C-REACTIVE PROTEIN is DCK.

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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.