The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Human O Buffer.
Device ID | K771956 |
510k Number | K771956 |
Device Name: | HUMAN O BUFFER |
Classification | Antisera, Hai (including Hai Control), Rubella |
Applicant | FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GOK |
CFR Regulation Number | 866.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-17 |
Decision Date | 1977-10-28 |