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510(k) K040174

BILIRUBIN ASSAY ON THE OMNI S ANALYZER by Roche Diagnostics Corp. — Product Code MQM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2004
Date Received
January 26, 2004
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

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Other clearances for product code MQM

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  • 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)
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  • K001687 — COLORMATE TLC BILITEST SYSTEM (September 13, 2001)
  • K010052 — RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER (March 19, 2001)
  • K994438 — BILICHEK NON-INVASIVE BILIRUBIN ANALYZER (February 4, 2000)