Il Synthesis--Addition of Bilirubin AS a Measured Parameter for Neonate Whole Blood Samples
FDA 510(k) K980646 · Instrumentation Laboratory CO
510(k) numberK980646
Submission
- Device name
- Il Synthesis--Addition of Bilirubin AS a Measured Parameter for Neonate Whole Blood Samples
- Applicant
- Instrumentation Laboratory CO
Lexington, MA, US - Received
- February 19, 1998
- Decision date
- May 6, 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
Other 510(k)s with product code MQM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170882 | ABL90 Flex, ABL90 Flex PlusMQM · Traditional | Radiometer Medical Aps | 04/28/2017SE |
| 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 |
More from Respironics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233790 | Acl Top 970 CLJPA · Special | 12/29/2023SE |
| K230852 | HemosIL Chromogenic Factor IXGGP · Traditional | 12/13/2023SE |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional | 09/29/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | 08/10/2023SE |
| K223187 | HemosIL Liquid Anti-XaQLU · Traditional | 06/23/2023SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | 06/21/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
| K213464 | HemosIL Liquid Anti-XaKFF · Special | 10/04/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | 08/16/2022SE |
Questions and answers
When was Il Synthesis--Addition of Bilirubin AS a Measured Parameter for Neonate Whole Blood Samples cleared by the FDA?
Il Synthesis--Addition of Bilirubin AS a Measured Parameter for Neonate Whole Blood Samples (K980646) received a 510(k) decision of Substantially Equivalent on May 6, 1998, 76 days after the submission was received.
What is the product code of K980646?
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.