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FDA 510(k)

NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA

K-Number: K801346 · 1980-08-12

ApplicantNobel Scientific Industries, Inc.
Decision Date1980-08-12
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Scientific Industries, Inc.. It received FDA 510(k) clearance on 1980-08-12 under 510(k) number K801346. 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 NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA?

NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA is a medical device that received FDA 510(k) clearance on 1980-08-12. The listed applicant is Nobel Scientific Industries, Inc.. The 510(k) number is K801346.

When did NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA receive FDA 510(k) clearance?

NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA received FDA 510(k) clearance on 1980-08-12, under 510(k) number K801346.

Who is the listed applicant for NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA?

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

What is the FDA product code for NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA?

The FDA product code for NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA is GIF.

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Other records listing Nobel Scientific Industries, Inc. as applicant

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K854717NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928K854716NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909K854718NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926K850944NSI LYSING-D REAGENT -4000 MLK844782NSI ELT-D DILUTING FLUID 4000MLK823283FLUSHING SOLUTION

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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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