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510(k) K001687

COLORMATE TLC BILITEST SYSTEM by Chromatics Color Sciences Intl., Inc. — Product Code MQM

K001687 is an FDA 510(k) premarket notification submitted by Chromatics Color Sciences Intl., Inc. for the device "COLORMATE TLC BILITEST SYSTEM". The FDA issued a decision of Substantially Equivalent on September 13, 2001. The device falls under product code MQM (Bilirubin (Total And Unbound) In The Neonate Test System), a Class I device regulated under 21 CFR 862.1113. Chromatics Color Sciences Intl., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2001
Date Received
June 1, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bilirubin (Total And Unbound) In The Neonate Test System
Device Class
Class I
Regulation Number
862.1113
Review Panel
CH
Submission Type

Other clearances by Chromatics Color Sciences Intl., Inc.

  • K964590 — COLORMATE III (July 24, 1997)

Other clearances for product code MQM

  • K170882 — ABL90 FLEX, ABL90 FLEX PLUS (April 28, 2017)
  • K132691 — ABL90 FLEX (November 13, 2014)
  • K133175 — DRAEGER JAUNDICE METER JM-105 (November 13, 2014)
  • K110277 — RAPIDPOINT 405 NEONATAL BILIRUBIN (August 15, 2011)
  • K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 (June 27, 2008)
  • K042522 — JAUNDICE METER, MODEL JM 103 (July 6, 2005)
  • K040174 — BILIRUBIN ASSAY ON THE OMNI S ANALYZER (May 14, 2004)
  • K021622 — HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 (April 1, 2003)
  • K010052 — RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER (March 19, 2001)
  • K994438 — BILICHEK NON-INVASIVE BILIRUBIN ANALYZER (February 4, 2000)

FDA data resources