The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Miles Auto Meth Determin Of Uric Acid In Urine.
Device ID | K924129 |
510k Number | K924129 |
Device Name: | MILES AUTO METH DETERMIN OF URIC ACID IN URINE |
Classification | Acid, Uric, Uricase (colorimetric) |
Applicant | HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
Contact | Robert L Habig |
Correspondent | Robert L Habig HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
Product Code | KNK |
CFR Regulation Number | 862.1775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-17 |
Decision Date | 1992-09-22 |