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FDA 510(k)

HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)

K-Number: K944288 · 1994-10-03

ApplicantHemagen Diagnostics, Inc.
Decision Date1994-10-03
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) is the device name listed in this FDA 510(k) record. The listed applicant is Hemagen Diagnostics, Inc.. It received FDA 510(k) clearance on 1994-10-03 under 510(k) number K944288. 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 HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)?

HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) is a medical device that received FDA 510(k) clearance on 1994-10-03. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K944288.

When did HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) receive FDA 510(k) clearance?

HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) received FDA 510(k) clearance on 1994-10-03, under 510(k) number K944288.

Who is the listed applicant for HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)?

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

What is the FDA product code for HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)?

The FDA product code for HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) is DCK.

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Official Source

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