The following data is part of a premarket notification filed by Bioresource Technology, Inc. with the FDA for Liquitrol, Liquid Human Glycosyla,ted Hemoglobin (a1c) Control - Normal/abnormal.
| Device ID | K023032 |
| 510k Number | K023032 |
| Device Name: | LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL |
| Classification | Standards And Controls, Hemoglobin, Normal And Abnormal |
| Applicant | BIORESOURCE TECHNOLOGY, INC. 1531 N.W. 65TH AVE. Fort Lauderdale, FL 33313 -4542 |
| Contact | Alan Posner |
| Correspondent | Alan Posner BIORESOURCE TECHNOLOGY, INC. 1531 N.W. 65TH AVE. Fort Lauderdale, FL 33313 -4542 |
| Product Code | GFS |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-11 |
| Decision Date | 2002-10-08 |