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510(k) K010052

RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER by Respironics, Inc. — Product Code MQM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2001
Date Received
January 8, 2001
Clearance Type
Abbreviated
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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  • K042522 — JAUNDICE METER, MODEL JM 103 (July 6, 2005)
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  • K001687 — COLORMATE TLC BILITEST SYSTEM (September 13, 2001)
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