The following data is part of a premarket notification filed by Current Technologies, Inc. with the FDA for Arterial Micro Collection Kit.
Device ID | K833312 |
510k Number | K833312 |
Device Name: | ARTERIAL MICRO COLLECTION KIT |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | CURRENT TECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-22 |
Decision Date | 1983-12-08 |