510(k) K771867
K771867 is an FDA 510(k) premarket notification submitted by Bioassay Systems Research Corp. for the device "MYCOPLASMA DETECTION KIT". The FDA issued a decision of Substantially Equivalent on November 17, 1977. The device falls under product code KPB (Media And Components, Mycoplasma Detection), a Class I device regulated under 21 CFR 864.2360. Bioassay Systems Research Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 1977
- Date Received
- October 3, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media And Components, Mycoplasma Detection
- Device Class
- Class I
- Regulation Number
- 864.2360
- Review Panel
- PA
- Submission Type