510(k) K863071
- Device
- PHOSPHOLIPIDS-E
- Applicant
- J. D. ASSOC.
- 510(k) number
- K863071
- Product code
- CEQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-09-09
- Date received
- 1986-08-12
- Regulation
- 862.1575
- Classification name
- Molybdenum Blue Method, Phospholipids
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DI PIETRO
- Address
- 163 Montclair Ave. Montclair NJ US 07042 07042
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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