The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Potassium Test.
Device ID | K863486 |
510k Number | K863486 |
Device Name: | POTASSIUM TEST |
Classification | Tetraphenyl Borate, Colorimetry, Potassium |
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 | CEJ |
CFR Regulation Number | 862.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-09 |
Decision Date | 1986-09-29 |