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FDA 510(k)

HYCEL QUICK-LYSING HEMOGLOBIN REAGENT

K-Number: K882490 · 1988-07-25

ApplicantR&D Systems, Inc.
Decision Date1988-07-25
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HYCEL QUICK-LYSING HEMOGLOBIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is R&D Systems, Inc.. It received FDA 510(k) clearance on 1988-07-25 under 510(k) number K882490. 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 HYCEL QUICK-LYSING HEMOGLOBIN REAGENT?

HYCEL QUICK-LYSING HEMOGLOBIN REAGENT is a medical device that received FDA 510(k) clearance on 1988-07-25. The listed applicant is R&D Systems, Inc.. The 510(k) number is K882490.

When did HYCEL QUICK-LYSING HEMOGLOBIN REAGENT receive FDA 510(k) clearance?

HYCEL QUICK-LYSING HEMOGLOBIN REAGENT received FDA 510(k) clearance on 1988-07-25, under 510(k) number K882490.

Who is the listed applicant for HYCEL QUICK-LYSING HEMOGLOBIN REAGENT?

The FDA 510(k) record lists R&D Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYCEL QUICK-LYSING HEMOGLOBIN REAGENT?

The FDA product code for HYCEL QUICK-LYSING HEMOGLOBIN REAGENT is GIF.

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Other records listing R&D Systems, 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.

K160606BC-5D Hematology ControlK130962R&D 5D RETIC HEMATOLOGY CONTROLK101578R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROLK100050R & D SYSTEMS XERET HEMATOLOGY CONTROLK091433R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROLK073178HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004

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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.K882267SYSMEX QUICKLYSER-II (QLS-200A)Toa Medical Electronics USA, 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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