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FDA 510(k)

BUN REAGENT ASTRA 4 & 8 ANALYZERS

K-Number: K802518 · 1980-11-12

ApplicantNobel Scientific Industries, Inc.
Decision Date1980-11-12
Product CodeCDN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BUN REAGENT ASTRA 4 & 8 ANALYZERS 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 1980-11-12 under 510(k) number K802518. The device is classified under product code CDN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUN REAGENT ASTRA 4 & 8 ANALYZERS?

BUN REAGENT ASTRA 4 & 8 ANALYZERS is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Nobel Scientific Industries, Inc.. The 510(k) number is K802518.

When did BUN REAGENT ASTRA 4 & 8 ANALYZERS receive FDA 510(k) clearance?

BUN REAGENT ASTRA 4 & 8 ANALYZERS received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802518.

Who is the listed applicant for BUN REAGENT ASTRA 4 & 8 ANALYZERS?

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 BUN REAGENT ASTRA 4 & 8 ANALYZERS?

The FDA product code for BUN REAGENT ASTRA 4 & 8 ANALYZERS is CDN.

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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: CDN)

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.

K190326VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc.K132462S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CREHitachi Chemical Diagnostics, Inc.K123322ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENTAlfa Wassermann Diagnostics Technologies, LLCK113389ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K103615ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARDAlfa Wassermann Diagnostic Technologies, Inc.K001885VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1Ortho-Clinical Diagnostics, Inc.

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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