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FDA 510(k)

BILICHEK NON-INVASIVE BILIRUBIN ANALYZER

K-Number: K994438 · 2000-02-04

ApplicantSpectrx, Inc.
Decision Date2000-02-04
Product CodeMQM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILICHEK NON-INVASIVE BILIRUBIN ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Spectrx, Inc.. It received FDA 510(k) clearance on 2000-02-04 under 510(k) number K994438. 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 BILICHEK NON-INVASIVE BILIRUBIN ANALYZER?

BILICHEK NON-INVASIVE BILIRUBIN ANALYZER is a medical device that received FDA 510(k) clearance on 2000-02-04. The listed applicant is Spectrx, Inc.. The 510(k) number is K994438.

When did BILICHEK NON-INVASIVE BILIRUBIN ANALYZER receive FDA 510(k) clearance?

BILICHEK NON-INVASIVE BILIRUBIN ANALYZER received FDA 510(k) clearance on 2000-02-04, under 510(k) number K994438.

Who is the listed applicant for BILICHEK NON-INVASIVE BILIRUBIN ANALYZER?

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

What is the FDA product code for BILICHEK NON-INVASIVE BILIRUBIN ANALYZER?

The FDA product code for BILICHEK NON-INVASIVE BILIRUBIN ANALYZER is MQM.

Related Clinical Trials

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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Other records listing Spectrx, 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.

K051045SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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