Unistat Bilirubinometer Models 10310 and 10311
FDA 510(k) K922770 · Leica, Inc.
510(k) numberK922770
Submission
- Device name
- Unistat Bilirubinometer Models 10310 and 10311
- Applicant
- Leica, Inc.
Buffalo, NY, US - Received
- June 9, 1992
- Decision date
- August 18, 1992
- 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.
Questions and answers
When was Unistat Bilirubinometer Models 10310 and 10311 cleared by the FDA?
Unistat Bilirubinometer Models 10310 and 10311 (K922770) received a 510(k) decision of Substantially Equivalent on August 18, 1992, 70 days after the submission was received.
What is the product code of K922770?
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.