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FDA 510(k)

CHOLESTECH BUN/CREATININE TEST SYSTEM

K-Number: K972012 · 1997-07-24

ApplicantCholestech Corp.
Decision Date1997-07-24
Product CodeCDN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTECH BUN/CREATININE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cholestech Corp.. It received FDA 510(k) clearance on 1997-07-24 under 510(k) number K972012. 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 CHOLESTECH BUN/CREATININE TEST SYSTEM?

CHOLESTECH BUN/CREATININE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1997-07-24. The listed applicant is Cholestech Corp.. The 510(k) number is K972012.

When did CHOLESTECH BUN/CREATININE TEST SYSTEM receive FDA 510(k) clearance?

CHOLESTECH BUN/CREATININE TEST SYSTEM received FDA 510(k) clearance on 1997-07-24, under 510(k) number K972012.

Who is the listed applicant for CHOLESTECH BUN/CREATININE TEST SYSTEM?

The FDA 510(k) record lists Cholestech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOLESTECH BUN/CREATININE TEST SYSTEM?

The FDA product code for CHOLESTECH BUN/CREATININE TEST SYSTEM is CDN.

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Other records listing Cholestech Corp. as applicant

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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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