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510(k) K073537

NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 by Siemens Medical Solutions Diagnostics — Product Code MQM

K073537 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions Diagnostics for the device "NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265". The FDA issued a decision of Substantially Equivalent on June 27, 2008. 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. Siemens Medical Solutions Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2008
Date Received
December 17, 2007
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 Siemens Medical Solutions Diagnostics

  • K100910 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (May 11, 2011)
  • K091984 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (October 28, 2009)
  • K081895 — ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS (January 8, 2009)
  • K071455 — ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR (September 11, 2008)
  • K072658 — ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS (April 1, 2008)
  • K072794 — IMMULITE 2500 OM-MA, MODEL L5KOP (November 5, 2007)
  • K071466 — DCA VANTAGE, MODEL 5075 (October 9, 2007)
  • K072204 — ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS (October 5, 2007)
  • K070727 — ADVIA CHEMISTRY ENZYMATIC CREATININE_2 (August 3, 2007)
  • K071017 — IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5 (May 2, 2007)

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)
  • 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)
  • K994438 — BILICHEK NON-INVASIVE BILIRUBIN ANALYZER (February 4, 2000)

FDA data resources