The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Chloride Test.
Device ID | K870630 |
510k Number | K870630 |
Device Name: | CHLORIDE TEST |
Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
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 | CHJ |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-13 |
Decision Date | 1987-04-22 |