Draeger Jaundice Meter JM-105
FDA 510(k) K133175 · Draeger Medical Systems, Inc.
510(k) numberK133175
Submission
- Device name
- Draeger Jaundice Meter JM-105
- Applicant
- Draeger Medical Systems, Inc.
Telford, PA, US - Received
- October 17, 2013
- Decision date
- November 13, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQM – Bilirubin (Total And Unbound) In The Neonate Test System
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1113
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K170882 | ABL90 Flex, ABL90 Flex PlusMQM · Traditional | Radiometer Medical Aps | 04/28/2017SE |
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| K110277 | Rapidpoint 405 Neonatal BilirubinMQM · Traditional | Siemens Healthcare Diagnostics | 08/15/2011SE |
| K073537 | Neonatal Bilirubin on Rapidlab Models 1245 and 1265MQM · Traditional | Siemens Medical Solutions Diagnostics | 06/27/2008SE |
| K042522 | Jaundice Meter, Model JM 103MQM · Traditional | Draeger Medical Infant Care, Inc. | 07/06/2005SE |
| K040174 | Bilirubin Assay on the Omni S AnalyzerMQM · Traditional | Roche Diagnostics Corp. | 05/14/2004SE |
| K021622 | Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103MQM · Traditional | Hill-Rom Air-Shields | 04/01/2003SE |
| K001687 | Colormate TLC Bilitest SystemMQM · Traditional | Chromatics Color Sciences Intl., Inc. | 09/13/2001SE |
| K010052 | Respironics Bilichek NON-INVASIVE-100-0800-20; Bilirubin AnalyzerMQM · Abbreviated | Respironics, Inc. | 03/19/2001SE |
| K994438 | Bilichek Non-Invasive Bilirubin AnalyzerMQM · Traditional | Spectrx, Inc. | 02/04/2000SE |
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Questions and answers
When was Draeger Jaundice Meter JM-105 cleared by the FDA?
Draeger Jaundice Meter JM-105 (K133175) received a 510(k) decision of Substantially Equivalent on November 13, 2014, 392 days after the submission was received.
What is the product code of K133175?
The FDA product code is MQM – Bilirubin (Total And Unbound) In The Neonate Test System, a Class I (low risk) device regulated under 21 CFR 862.1113.