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FDA 510(k)

TOTAL BILIRUBIN STANDARDS

K-Number: K852068 · 1985-05-31

ApplicantData Medical Associates, Inc.
Decision Date1985-05-31
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL BILIRUBIN STANDARDS is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1985-05-31 under 510(k) number K852068. 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 TOTAL BILIRUBIN STANDARDS?

TOTAL BILIRUBIN STANDARDS is a medical device that received FDA 510(k) clearance on 1985-05-31. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K852068.

When did TOTAL BILIRUBIN STANDARDS receive FDA 510(k) clearance?

TOTAL BILIRUBIN STANDARDS received FDA 510(k) clearance on 1985-05-31, under 510(k) number K852068.

Who is the listed applicant for TOTAL BILIRUBIN STANDARDS?

The FDA 510(k) record lists Data Medical Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL BILIRUBIN STANDARDS?

The FDA product code for TOTAL BILIRUBIN STANDARDS is JIS.

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Other records listing Data Medical Associates, 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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