The following data is part of a premarket notification filed by Starplex Scientific, Inc. with the FDA for Vacuplus Tubes With Lavander Stoppers.
Device ID | K924362 |
510k Number | K924362 |
Device Name: | VACUPLUS TUBES WITH LAVANDER STOPPERS |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | STARPLEX SCIENTIFIC, INC. 50 STEINWAY BLVD. UNIT #5 Etobicoke, Ontario, CA M9w 6y3 |
Contact | Mehdi Karamchi |
Correspondent | Mehdi Karamchi STARPLEX SCIENTIFIC, INC. 50 STEINWAY BLVD. UNIT #5 Etobicoke, Ontario, CA M9w 6y3 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-28 |
Decision Date | 1993-03-01 |