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FDA 510(k)

QUANTIMETRIX BILIRUBIN CALIBRATORS

K-Number: K895778 · 1989-11-14

ApplicantQuantimetrix Medical Industries
Decision Date1989-11-14
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIMETRIX BILIRUBIN CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Medical Industries. It received FDA 510(k) clearance on 1989-11-14 under 510(k) number K895778. 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 QUANTIMETRIX BILIRUBIN CALIBRATORS?

QUANTIMETRIX BILIRUBIN CALIBRATORS is a medical device that received FDA 510(k) clearance on 1989-11-14. The listed applicant is Quantimetrix Medical Industries. The 510(k) number is K895778.

When did QUANTIMETRIX BILIRUBIN CALIBRATORS receive FDA 510(k) clearance?

QUANTIMETRIX BILIRUBIN CALIBRATORS received FDA 510(k) clearance on 1989-11-14, under 510(k) number K895778.

Who is the listed applicant for QUANTIMETRIX BILIRUBIN CALIBRATORS?

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

What is the FDA product code for QUANTIMETRIX BILIRUBIN CALIBRATORS?

The FDA product code for QUANTIMETRIX BILIRUBIN CALIBRATORS is JIS.

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Other records listing Quantimetrix Medical Industries 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.

K883395ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZYK883247LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROLK874302QUANTIMETRIX TOTAL CREATINE KINASE CONTROLK874890QUANTIMETRIX URINE DIPSTICK CONTROLK873011QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2K873467QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL

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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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