510(k) K890269
- Device
- Alkaline Phosphatase Isoenzyme Reagents
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K890269
- Product code
- CIN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-03-08
- Date received
- 1989-01-18
- Regulation
- 862.1050
- Classification name
- Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM T RYAN
- Address
- 200 S. Kraemer Blvd., W-337 Box 8000 Brea CA US 92622 92622
FDA Registration Numbers#
- 8023024
- 2182595
- 3007118747
- 8021924
- 9610102
- 1528450
- 1618982
- 2122870
Source Documents#
510(k) summary PDF not indicated by FDA
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