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FDA 510(k)

HEMORAM/AGGRAM ANALYZER

K-Number: K050053 · 2005-07-11

ApplicantHelena Laboratories
Decision Date2005-07-11
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMORAM/AGGRAM ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 2005-07-11 under 510(k) number K050053. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMORAM/AGGRAM ANALYZER?

HEMORAM/AGGRAM ANALYZER is a medical device that received FDA 510(k) clearance on 2005-07-11. The listed applicant is Helena Laboratories. The 510(k) number is K050053.

When did HEMORAM/AGGRAM ANALYZER receive FDA 510(k) clearance?

HEMORAM/AGGRAM ANALYZER received FDA 510(k) clearance on 2005-07-11, under 510(k) number K050053.

Who is the listed applicant for HEMORAM/AGGRAM ANALYZER?

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 HEMORAM/AGGRAM ANALYZER?

The FDA product code for HEMORAM/AGGRAM ANALYZER is JPA.

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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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