The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Gamma Lewis Blood Group Substance.
| Device ID | K802533 |
| 510k Number | K802533 |
| Device Name: | GAMMA LEWIS BLOOD GROUP SUBSTANCE |
| Classification | Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use |
| Applicant | GAMMA BIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSX |
| CFR Regulation Number | 864.9160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-15 |
| Decision Date | 1980-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234000853 | K802533 | 000 |