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FDA 510(k)

MODIFIED BLOOD CELL COUNTING & LYSING

K-Number: K801357 · 1980-08-14

ApplicantCoulter Electronics, Inc.
Decision Date1980-08-14
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MODIFIED BLOOD CELL COUNTING & LYSING is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1980-08-14 under 510(k) number K801357. 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 MODIFIED BLOOD CELL COUNTING & LYSING?

MODIFIED BLOOD CELL COUNTING & LYSING is a medical device that received FDA 510(k) clearance on 1980-08-14. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K801357.

When did MODIFIED BLOOD CELL COUNTING & LYSING receive FDA 510(k) clearance?

MODIFIED BLOOD CELL COUNTING & LYSING received FDA 510(k) clearance on 1980-08-14, under 510(k) number K801357.

Who is the listed applicant for MODIFIED BLOOD CELL COUNTING & LYSING?

The FDA 510(k) record lists Coulter Electronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED BLOOD CELL COUNTING & LYSING?

The FDA product code for MODIFIED BLOOD CELL COUNTING & LYSING is GIF.

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Other records listing Coulter Electronics, Inc. as applicant

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K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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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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