The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Gamma Pi Blood Group Substance.
Device ID | K802534 |
510k Number | K802534 |
Device Name: | GAMMA PI 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 |
---|---|---|
10888234000846 | K802534 | 000 |