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FDA 510(k)

REAGENT FOR COULTER COUNTER MODEL 5+11

K-Number: K821683 · 1982-06-24

ApplicantFisher Scientific Co., LLC
Decision Date1982-06-24
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

REAGENT FOR COULTER COUNTER MODEL 5+11 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 1982-06-24 under 510(k) number K821683. The device is classified under product code GIF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT FOR COULTER COUNTER MODEL 5+11?

REAGENT FOR COULTER COUNTER MODEL 5+11 is a medical device that received FDA 510(k) clearance on 1982-06-24. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K821683.

When did REAGENT FOR COULTER COUNTER MODEL 5+11 receive FDA 510(k) clearance?

REAGENT FOR COULTER COUNTER MODEL 5+11 received FDA 510(k) clearance on 1982-06-24, under 510(k) number K821683.

Who is the listed applicant for REAGENT FOR COULTER COUNTER MODEL 5+11?

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 REAGENT FOR COULTER COUNTER MODEL 5+11?

The FDA product code for REAGENT FOR COULTER COUNTER MODEL 5+11 is GIF.

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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: GIF)

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.

K883989KVM ISOTONIC FLUSH SOLUTIONKvm Technologies, Inc.K883990KVM ISOTONIC DILUENTKvm Technologies, Inc.K882490HYCEL QUICK-LYSING HEMOGLOBIN REAGENTR&D Systems, Inc.K882267SYSMEX QUICKLYSER-II (QLS-200A)Toa Medical Electronics USA, Inc.K881130CELL-DYN ISOTONIC DILUENTAbbott DiagnosticsK873347CELL-DYN DIFF. SCREEN ISOTONIC DILUENTAbbott Diagnostics

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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