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FDA 510(k)

VARIOUS REAGENTS FOR BLOOD CELL ANALYZER

K-Number: K800180 · 1980-03-19

ApplicantLaboratory Products, Inc.
Decision Date1980-03-19
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VARIOUS REAGENTS FOR BLOOD CELL ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Laboratory Products, Inc.. It received FDA 510(k) clearance on 1980-03-19 under 510(k) number K800180. 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 VARIOUS REAGENTS FOR BLOOD CELL ANALYZER?

VARIOUS REAGENTS FOR BLOOD CELL ANALYZER is a medical device that received FDA 510(k) clearance on 1980-03-19. The listed applicant is Laboratory Products, Inc.. The 510(k) number is K800180.

When did VARIOUS REAGENTS FOR BLOOD CELL ANALYZER receive FDA 510(k) clearance?

VARIOUS REAGENTS FOR BLOOD CELL ANALYZER received FDA 510(k) clearance on 1980-03-19, under 510(k) number K800180.

Who is the listed applicant for VARIOUS REAGENTS FOR BLOOD CELL ANALYZER?

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

What is the FDA product code for VARIOUS REAGENTS FOR BLOOD CELL ANALYZER?

The FDA product code for VARIOUS REAGENTS FOR BLOOD CELL ANALYZER is GIF.

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Other records listing Laboratory Products, Inc. as applicant

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K832588CIN AGARK803051FLAME PHOTOMETRY REAGENTSK803013CHLORIDE/TCO2 ANALYZER REAGENTSK803050SPRAY, SYNTHETIC SMEARK792482CHEMISTRY ANALYZER REAGENTSK792481CULTURE PLATES & TUBED MEDIA

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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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