The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Fast Flow #60310.
Device ID | K791365 |
510k Number | K791365 |
Device Name: | FAST FLOW #60310 |
Classification | Assay, Glycosylated Hemoglobin |
Applicant | HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LCP |
CFR Regulation Number | 864.7470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-07-25 |
Decision Date | 1979-09-27 |