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FDA 510(k)

SCANLISA HUMAN CRP ELISA KIT

K-Number: K894573 · 1989-08-10

ApplicantImmuntech A/S
Decision Date1989-08-10
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SCANLISA HUMAN CRP ELISA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuntech A/S. It received FDA 510(k) clearance on 1989-08-10 under 510(k) number K894573. 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 SCANLISA HUMAN CRP ELISA KIT?

SCANLISA HUMAN CRP ELISA KIT is a medical device that received FDA 510(k) clearance on 1989-08-10. The listed applicant is Immuntech A/S. The 510(k) number is K894573.

When did SCANLISA HUMAN CRP ELISA KIT receive FDA 510(k) clearance?

SCANLISA HUMAN CRP ELISA KIT received FDA 510(k) clearance on 1989-08-10, under 510(k) number K894573.

Who is the listed applicant for SCANLISA HUMAN CRP ELISA KIT?

The FDA 510(k) record lists Immuntech A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCANLISA HUMAN CRP ELISA KIT?

The FDA product code for SCANLISA HUMAN CRP ELISA KIT is DCK.

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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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