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FDA 510(k)

ACA URINARY PROTEIN CALIBRATOR

K-Number: K822232 · 1982-08-16

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1982-08-16
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACA URINARY PROTEIN CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1982-08-16 under 510(k) number K822232. 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 ACA URINARY PROTEIN CALIBRATOR?

ACA URINARY PROTEIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K822232.

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

ACA URINARY PROTEIN CALIBRATOR received FDA 510(k) clearance on 1982-08-16, under 510(k) number K822232.

Who is the listed applicant for ACA URINARY PROTEIN CALIBRATOR?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACA URINARY PROTEIN CALIBRATOR?

The FDA product code for ACA URINARY PROTEIN CALIBRATOR is JIS.

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Other records listing E.I. Dupont DE Nemours & Co., 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.

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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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