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510(k) K922770

UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 by Leica, Inc. — Product Code MQM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1992
Date Received
June 9, 1992
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 Leica, Inc.

  • K951054 — XCEL SLIT LAMP (March 22, 1995)
  • K944022 — LENSCHEK (November 17, 1994)

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  • K133175 — DRAEGER JAUNDICE METER JM-105 (November 13, 2014)
  • K132691 — ABL90 FLEX (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)
  • K001687 — COLORMATE TLC BILITEST SYSTEM (September 13, 2001)
  • K010052 — RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER (March 19, 2001)