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FDA 510(k)

FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR

K-Number: K862318 · 1986-07-10

ApplicantFisher Scientific Co., LLC
Decision Date1986-07-10
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR 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 1986-07-10 under 510(k) number K862318. 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 HEMATALL-C CALIBRATOR?

FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR is a medical device that received FDA 510(k) clearance on 1986-07-10. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K862318.

When did FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR receive FDA 510(k) clearance?

FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR received FDA 510(k) clearance on 1986-07-10, under 510(k) number K862318.

Who is the listed applicant for FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR?

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 HEMATALL-C CALIBRATOR?

The FDA product code for FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR is JPK.

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Other records listing Fisher Scientific Co., LLC as applicant

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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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Related Devices (Code: JPK)

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.

K160586XN-L CHECKStreckK160590XN CHECKStreckK160588XN CHECK BFStreckK160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

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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