FDA 510(k)

FISHER DIAGNOSTICS HEMATOLOGY CONTROLS

K-Number: K792055 · 1979-11-05

Decision Date1979-11-05

Product CodeJPK

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

FISHER DIAGNOSTICS HEMATOLOGY CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1979-11-05 under 510(k) number K792055. 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 FISHER DIAGNOSTICS HEMATOLOGY CONTROLS?

FISHER DIAGNOSTICS HEMATOLOGY CONTROLS is a medical device that received FDA 510(k) clearance on 1979-11-05. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K792055.

When did FISHER DIAGNOSTICS HEMATOLOGY CONTROLS receive FDA 510(k) clearance?

FISHER DIAGNOSTICS HEMATOLOGY CONTROLS received FDA 510(k) clearance on 1979-11-05, under 510(k) number K792055.

Who is the listed applicant for FISHER DIAGNOSTICS HEMATOLOGY CONTROLS?

The FDA 510(k) record lists Fisher Scientific Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FISHER DIAGNOSTICS HEMATOLOGY CONTROLS?

The FDA product code for FISHER DIAGNOSTICS HEMATOLOGY CONTROLS is JPK.

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Other records listing Fisher Scientific Co., LLC as applicant

K930415MICROHEMATOCRIT ROTOR K915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGE K915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE K890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II K874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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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.