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FDA 510(k)

COLORMATE III

K-Number: K964590 · 1997-07-24

ApplicantChromatics Color Sciences Intl., Inc.
Decision Date1997-07-24
Product CodeMQM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COLORMATE III 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 1997-07-24 under 510(k) number K964590. 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 III?

COLORMATE III is a medical device that received FDA 510(k) clearance on 1997-07-24. The listed applicant is Chromatics Color Sciences Intl., Inc.. The 510(k) number is K964590.

When did COLORMATE III receive FDA 510(k) clearance?

COLORMATE III received FDA 510(k) clearance on 1997-07-24, under 510(k) number K964590.

Who is the listed applicant for COLORMATE III?

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 III?

The FDA product code for COLORMATE III 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.

K001687COLORMATE TLC BILITEST SYSTEM

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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