Rapidpoint 405 Neonatal Bilirubin
FDA 510(k) K110277 · Siemens Healthcare Diagnostics
510(k) numberK110277
Submission
- Device name
- Rapidpoint 405 Neonatal Bilirubin
- Applicant
- Siemens Healthcare Diagnostics
Norowood, MA, US - Received
- January 31, 2011
- Decision date
- August 15, 2011
- 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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| 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 Rapidpoint 405 Neonatal Bilirubin cleared by the FDA?
Rapidpoint 405 Neonatal Bilirubin (K110277) received a 510(k) decision of Substantially Equivalent on August 15, 2011, 196 days after the submission was received.
What is the product code of K110277?
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.