The following data is part of a premarket notification filed by Biosafe Laboratories, Inc. with the FDA for Biosafe Cholesterol Profile Blood Collection And Transport System.
| Device ID | K011970 |
| 510k Number | K011970 |
| Device Name: | BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | BIOSAFE LABORATORIES, INC. 100 FIELD DRIVE #240 Lake Forest, IL 60045 |
| Contact | Jack A Maggiore |
| Correspondent | Jack A Maggiore BIOSAFE LABORATORIES, INC. 100 FIELD DRIVE #240 Lake Forest, IL 60045 |
| Product Code | CHH |
| Subsequent Product Code | CDT |
| Subsequent Product Code | LBS |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-25 |
| Decision Date | 2001-09-26 |
| Summary: | summary |