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FDA 510(k)

URINARY ALBUMIN CALIBRATOR

K-Number: K936201 · 1994-03-11

ApplicantDupont Medical Products
Decision Date1994-03-11
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINARY ALBUMIN CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Dupont Medical Products. It received FDA 510(k) clearance on 1994-03-11 under 510(k) number K936201. 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 URINARY ALBUMIN CALIBRATOR?

URINARY ALBUMIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 1994-03-11. The listed applicant is Dupont Medical Products. The 510(k) number is K936201.

When did URINARY ALBUMIN CALIBRATOR receive FDA 510(k) clearance?

URINARY ALBUMIN CALIBRATOR received FDA 510(k) clearance on 1994-03-11, under 510(k) number K936201.

Who is the listed applicant for URINARY ALBUMIN CALIBRATOR?

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

What is the FDA product code for URINARY ALBUMIN CALIBRATOR?

The FDA product code for URINARY ALBUMIN CALIBRATOR is JIS.

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Other records listing Dupont Medical Products 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.

K952815DUPONT LIPASE CALIBRATORK950920DUPONT DIMENSION TOTAL PROTEIN METHODK952816LIPASE FLEX REAGENT CARTRIDGEK952412DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROLK945280DUPONT DIMENSION C-REACTIVE PROTEIN METHODK944932PHENOBARBITAL FLEX REAGENT CARTRIDGE

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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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