510(k) K883525
- Device
- OXALATE REAGENT
- Applicant
- SIGMA CHEMICAL CO.
- 510(k) number
- K883525
- Product code
- LPW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-10-25
- Date received
- 1988-08-17
- Regulation
- 862.1542
- Classification name
- System, Test, Oxalate
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MATHEW MADAPPALLY
- Address
- P.O. Box 14508 St. Louis MO US 63178 63178
FDA Registration Numbers#
- 2032900
- 9681576
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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