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FDA 510(k)

COAGULATION ARP

K-Number: K790826 · 1979-05-31

ApplicantHelena Laboratories
Decision Date1979-05-31
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAGULATION ARP is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1979-05-31 under 510(k) number K790826. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAGULATION ARP?

COAGULATION ARP is a medical device that received FDA 510(k) clearance on 1979-05-31. The listed applicant is Helena Laboratories. The 510(k) number is K790826.

When did COAGULATION ARP receive FDA 510(k) clearance?

COAGULATION ARP received FDA 510(k) clearance on 1979-05-31, under 510(k) number K790826.

Who is the listed applicant for COAGULATION ARP?

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

What is the FDA product code for COAGULATION ARP?

The FDA product code for COAGULATION ARP is JPK.

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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.

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