The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Iron Test.
Device ID | K881202 |
510k Number | K881202 |
Device Name: | IRON TEST |
Classification | Photometric Method, Iron (non-heme) |
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 | JIY |
CFR Regulation Number | 862.1410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-21 |
Decision Date | 1988-04-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IRON TEST 86150259 4717590 Live/Registered |
Fitness Publications, Inc. 2013-12-20 |