510(k) K963268
- Device
- GENESIS RMP
- Applicant
- TECAN U.S., INC.
- 510(k) number
- K963268
- Product code
- JRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-03-18
- Date received
- 1996-08-20
- Regulation
- 862.2680
- Classification name
- Microtitrator, For Clinical Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTY LYCAN
- Address
- P.O. Box 13953 Research Triangle Park NC US 27709 27709
FDA Registration Numbers#
- 3016919945
- 3004493545
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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