510(k) K863287
- Device
- URIC ACID (URICASE) METHOD-II
- Applicant
- CATACHEM, INC.
- 510(k) number
- K863287
- Product code
- JHC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-09-29
- Date received
- 1986-08-25
- Regulation
- 862.1775
- Classification name
- Acid, Uric, Uricase (oxygen Rate)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LUIS P LEON
- Address
- 6 N. Pearl St. Port Chester NY US 10573 10573
FDA Registration Numbers#
- 3010891909
- 3010825766
- 2517506
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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