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FDA 510(k)

NSI CALIBRATOR SET

K-Number: K800588 · 1980-04-04

ApplicantNobel Scientific Industries, Inc.
Decision Date1980-04-04
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NSI CALIBRATOR SET 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 1980-04-04 under 510(k) number K800588. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NSI CALIBRATOR SET?

NSI CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 1980-04-04. The listed applicant is Nobel Scientific Industries, Inc.. The 510(k) number is K800588.

When did NSI CALIBRATOR SET receive FDA 510(k) clearance?

NSI CALIBRATOR SET received FDA 510(k) clearance on 1980-04-04, under 510(k) number K800588.

Who is the listed applicant for NSI CALIBRATOR SET?

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 CALIBRATOR SET?

The FDA product code for NSI CALIBRATOR SET is JIS.

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Other records listing Nobel Scientific Industries, 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.

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: JIS)

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.

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories LimitedK061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB

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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