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FDA 510(k)

PICOSCAL BLOOD CELL COUNTER PS-4

K-Number: K842140 · 1984-08-16

ApplicantDiagnostic Technology, Inc.
Decision Date1984-08-16
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PICOSCAL BLOOD CELL COUNTER PS-4 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 1984-08-16 under 510(k) number K842140. 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 PICOSCAL BLOOD CELL COUNTER PS-4?

PICOSCAL BLOOD CELL COUNTER PS-4 is a medical device that received FDA 510(k) clearance on 1984-08-16. The listed applicant is Diagnostic Technology, Inc.. The 510(k) number is K842140.

When did PICOSCAL BLOOD CELL COUNTER PS-4 receive FDA 510(k) clearance?

PICOSCAL BLOOD CELL COUNTER PS-4 received FDA 510(k) clearance on 1984-08-16, under 510(k) number K842140.

Who is the listed applicant for PICOSCAL BLOOD CELL COUNTER PS-4?

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 PICOSCAL BLOOD CELL COUNTER PS-4?

The FDA product code for PICOSCAL BLOOD CELL COUNTER PS-4 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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