The following data is part of a premarket notification filed by Bioassay Systems Research Corp. with the FDA for Mycoplasma Detection Kit.
| Device ID | K771867 |
| 510k Number | K771867 |
| Device Name: | MYCOPLASMA DETECTION KIT |
| Classification | Media And Components, Mycoplasma Detection |
| Applicant | BIOASSAY SYSTEMS RESEARCH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPB |
| CFR Regulation Number | 864.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-03 |
| Decision Date | 1977-11-17 |