The following data is part of a premarket notification filed by Microbio-medics, Inc. with the FDA for Microtek Medical's Blood Collection Kit.
Device ID | K900726 |
510k Number | K900726 |
Device Name: | MICROTEK MEDICAL'S BLOOD COLLECTION KIT |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | MICROBIO-MEDICS, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
Contact | A Smallwood |
Correspondent | A Smallwood MICROBIO-MEDICS, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-15 |
Decision Date | 1990-05-04 |