The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Creatinine 340 (enzymatic).
Device ID | K895847 |
510k Number | K895847 |
Device Name: | CREATININE 340 (ENZYMATIC) |
Classification | Alkaline Picrate, Colorimetry, Creatinine |
Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
Contact | King, Ph.d. |
Correspondent | King, Ph.d. SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
Product Code | CGX |
CFR Regulation Number | 862.1225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-03 |
Decision Date | 1989-10-30 |