Nbil
FDA 510(k) K983134 · Abbott Laboratories
510(k) numberK983134
Submission
- Device name
- Nbil
- Applicant
- Abbott Laboratories
Irving, TX, US - Received
- September 8, 1998
- Decision date
- September 23, 1998
- 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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|---|---|---|---|
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| K133175 | Draeger Jaundice Meter JM-105MQM · Traditional | Draeger Medical Systems, Inc. | 11/13/2014SE |
| K132691 | ABL90 FlexMQM · Traditional | Radiometer Medical Aps | 11/13/2014SE |
| 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 |
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Questions and answers
When was Nbil cleared by the FDA?
Nbil (K983134) received a 510(k) decision of Substantially Equivalent on September 23, 1998, 15 days after the submission was received.
What is the product code of K983134?
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.