510(k) K860501
- Device
- FLAME PHOTOMETER STANDARD
- Applicant
- MEDICAL SPECIALTIES, INC.
- 510(k) number
- K860501
- Product code
- JLJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-04-07
- Date received
- 1986-02-11
- Regulation
- 862.1315
- Classification name
- Uridine-5-diphosphoglucose, Nad (u.v.), Alpha-d Galactose-1-phosphate
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD DEVITA
- Address
- 3610 Kennedy Rd. South Plainfield NJ US 07080 07080
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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