UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311— 510(k) K922770

Name: FDA 510(k) clearance K922770
Creator: U.S. Food and Drug Administration
Published: 1992-08-18

Substantially Equivalent

Leica, Inc.

FDA 510(k) clearance K922770 for UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311, Substantially Equivalent on 1992-08-18. Applicant: Leica, Inc.. Device class: 1.

Clearance details

Applicant: Leica, Inc.
Product code: Code MQM
Device class: Class 1
Regulation: 21 CFR 862.1113
Advisory panel: Clinical Chemistry
Date received: 1992-06-09
Decision date: 1992-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQM

view all

K170882 — ABL90 FLEX, ABL90 FLEX PLUS2017-04-28
K132691 — ABL90 FLEX2014-11-13
K133175 — DRAEGER JAUNDICE METER JM-1052014-11-13
K110277 — RAPIDPOINT 405 NEONATAL BILIRUBIN2011-08-15
K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 12652008-06-27

More clearances from Leica, Inc.

view all

K951054 — XCEL SLIT LAMP1995-03-22
K944022 — LENSCHEK1994-11-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.