The following data is part of a premarket notification filed by Bioresource Technology, Inc. with the FDA for Bioresource Technology Liquichemtrol-normal Liquid Heman Protein Electrophoresis Control.
| Device ID | K944728 |
| 510k Number | K944728 |
| Device Name: | BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN ELECTROPHORESIS CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIORESOURCE TECHNOLOGY, INC. 4970 SOUTHWEST 52 ST. SUITE 325 Fort Lauderdale, FL 33311 |
| Contact | Alan Posner |
| Correspondent | Alan Posner BIORESOURCE TECHNOLOGY, INC. 4970 SOUTHWEST 52 ST. SUITE 325 Fort Lauderdale, FL 33311 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-26 |
| Decision Date | 1995-03-23 |