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FDA 510(k)

PICOSCALE BLOOD CELL COUNTER, MODEL PS-5

K-Number: K860166 · 1986-04-04

ApplicantDiagnostic Technology, Inc.
Decision Date1986-04-04
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 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 1986-04-04 under 510(k) number K860166. 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 PICOSCALE BLOOD CELL COUNTER, MODEL PS-5?

PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 is a medical device that received FDA 510(k) clearance on 1986-04-04. The listed applicant is Diagnostic Technology, Inc.. The 510(k) number is K860166.

When did PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 receive FDA 510(k) clearance?

PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 received FDA 510(k) clearance on 1986-04-04, under 510(k) number K860166.

Who is the listed applicant for PICOSCALE BLOOD CELL COUNTER, MODEL PS-5?

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 PICOSCALE BLOOD CELL COUNTER, MODEL PS-5?

The FDA product code for PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 is GKL.

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Related Devices (Code: GKL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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