The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Unifast Calcium Test.
Device ID | K864661 |
510k Number | K864661 |
Device Name: | UNIFAST CALCIUM TEST |
Classification | Cresolphthalein Complexone, Calcium |
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 | CIC |
CFR Regulation Number | 862.1145 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-28 |
Decision Date | 1987-02-04 |