The following data is part of a premarket notification filed by Biosafe Laboratories, Inc. with the FDA for Anemiapro Self-screener.
| Device ID | K042379 |
| 510k Number | K042379 |
| Device Name: | ANEMIAPRO SELF-SCREENER |
| Classification | Whole Blood Hemoglobin Determination |
| 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 | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-01 |
| Decision Date | 2004-12-15 |
| Summary: | summary |