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FDA 510(k)

IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES

K-Number: K980646 · 1998-05-06

ApplicantInstrumentation Laboratory CO
Decision Date1998-05-06
Product CodeMQM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1998-05-06 under 510(k) number K980646. The device is classified under product code MQM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES?

IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES is a medical device that received FDA 510(k) clearance on 1998-05-06. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K980646.

When did IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES receive FDA 510(k) clearance?

IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES received FDA 510(k) clearance on 1998-05-06, under 510(k) number K980646.

Who is the listed applicant for IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES?

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

What is the FDA product code for IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES?

The FDA product code for IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES is MQM.

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K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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Related Devices (Code: MQM)

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.

K170882ABL90 FLEX, ABL90 FLEX PLUSRadiometer Medical ApsK110277RAPIDPOINT 405 NEONATAL BILIRUBINSiemens Healthcare DiagnosticsK073537NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265Siemens Medical Solutions DiagnosticsK042522JAUNDICE METER, MODEL JM 103Draeger Medical Infant Care, Inc.K040174BILIRUBIN ASSAY ON THE OMNI S ANALYZERRoche Diagnostics Corp.K021622HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103Hill-Rom Air-Shields

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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