The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Gamma Fetal Bleed Screening Test.
| Device ID | K820647 |
| 510k Number | K820647 |
| Device Name: | GAMMA FETAL BLEED SCREENING TEST |
| Classification | Test, Screening, For D Positive Fetal Rbc's |
| Applicant | GAMMA BIOLOGICALS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LIM |
| CFR Regulation Number | 864.7455 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-09 |
| Decision Date | 1982-05-12 |