510(k) K880344
- Device
- Iq Alkaline Phosphatase
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K880344
- Product code
- CJK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-03-01
- Date received
- 1988-01-26
- Regulation
- 862.1050
- Classification name
- Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- J ARNSBERGER
- Address
- 1 Becton Dr. Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 3004493545
- 2432235
Source Documents#
510(k) summary PDF not indicated by FDA