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FDA 510(k)

SYSMEX QUICKLYSER-II (QLS-200A)

K-Number: K882267 · 1988-07-12

ApplicantToa Medical Electronics USA, Inc.
Decision Date1988-07-12
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX QUICKLYSER-II (QLS-200A) is the device name listed in this FDA 510(k) record. The listed applicant is Toa Medical Electronics USA, Inc.. It received FDA 510(k) clearance on 1988-07-12 under 510(k) number K882267. 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 SYSMEX QUICKLYSER-II (QLS-200A)?

SYSMEX QUICKLYSER-II (QLS-200A) is a medical device that received FDA 510(k) clearance on 1988-07-12. The listed applicant is Toa Medical Electronics USA, Inc.. The 510(k) number is K882267.

When did SYSMEX QUICKLYSER-II (QLS-200A) receive FDA 510(k) clearance?

SYSMEX QUICKLYSER-II (QLS-200A) received FDA 510(k) clearance on 1988-07-12, under 510(k) number K882267.

Who is the listed applicant for SYSMEX QUICKLYSER-II (QLS-200A)?

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

What is the FDA product code for SYSMEX QUICKLYSER-II (QLS-200A)?

The FDA product code for SYSMEX QUICKLYSER-II (QLS-200A) is GIF.

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Other records listing Toa Medical Electronics USA, Inc. 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.

K936023SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZERK933886TOA MEDICAL ELECTRONICS CA-5000K931149CA-1000 AUTOMATED COAGULATION ANALYZERK920544SYSMEX HEMATOLOGY SYSTEM ACCESSORIESK914744SYSMEX NE-1500, MODIFICATIONK912494SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER

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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.K881130CELL-DYN ISOTONIC DILUENTAbbott DiagnosticsK873347CELL-DYN DIFF. SCREEN ISOTONIC DILUENTAbbott DiagnosticsK851843OSMOCEL 3Hematology Marketing Assoc.

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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