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FDA 510(k)

COLORMATE TLC BILITEST SYSTEM

K-Number: K001687 · 2001-09-13

ApplicantChromatics Color Sciences Intl., Inc.
Decision Date2001-09-13
Product CodeMQM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COLORMATE TLC BILITEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Chromatics Color Sciences Intl., Inc.. It received FDA 510(k) clearance on 2001-09-13 under 510(k) number K001687. 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 COLORMATE TLC BILITEST SYSTEM?

COLORMATE TLC BILITEST SYSTEM is a medical device that received FDA 510(k) clearance on 2001-09-13. The listed applicant is Chromatics Color Sciences Intl., Inc.. The 510(k) number is K001687.

When did COLORMATE TLC BILITEST SYSTEM receive FDA 510(k) clearance?

COLORMATE TLC BILITEST SYSTEM received FDA 510(k) clearance on 2001-09-13, under 510(k) number K001687.

Who is the listed applicant for COLORMATE TLC BILITEST SYSTEM?

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

What is the FDA product code for COLORMATE TLC BILITEST SYSTEM?

The FDA product code for COLORMATE TLC BILITEST SYSTEM 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 Chromatics Color Sciences Intl., 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.

K964590COLORMATE III

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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