The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Fast Uric Acid.
Device ID | K870632 |
510k Number | K870632 |
Device Name: | FAST URIC ACID |
Classification | Acid, Uric, Uricase (colorimetric) |
Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
Contact | Debra Hofmeister |
Correspondent | Debra Hofmeister SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
Product Code | KNK |
CFR Regulation Number | 862.1775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-13 |
Decision Date | 1987-03-13 |