The following data is part of a premarket notification filed by Biosafe Laboratories, Inc. with the FDA for Safe At Home Cholesterol Profile Blood Collection And Transport System.
| Device ID | K012221 |
| 510k Number | K012221 |
| Device Name: | SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| 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 | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2002-04-03 |
| Summary: | summary |