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FDA 510(k)

PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS

K-Number: K860586 · 1986-05-07

ApplicantDiagnostic Technology, Inc.
Decision Date1986-05-07
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Technology, Inc.. It received FDA 510(k) clearance on 1986-05-07 under 510(k) number K860586. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS?

PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS is a medical device that received FDA 510(k) clearance on 1986-05-07. The listed applicant is Diagnostic Technology, Inc.. The 510(k) number is K860586.

When did PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS receive FDA 510(k) clearance?

PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS received FDA 510(k) clearance on 1986-05-07, under 510(k) number K860586.

Who is the listed applicant for PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS?

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

What is the FDA product code for PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS?

The FDA product code for PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS is GKL.

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Related Devices (Code: GKL)

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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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