510(k) K852933
K852933 is an FDA 510(k) premarket notification submitted by Microbix Biosystems, Inc. for the device "MYCOPLASMA SPP SEROLOGICAL REAGENTS". The FDA issued a decision of Substantially Equivalent on August 1, 1985. The device falls under product code GSB (Antigens, Cf, All, Mycoplasma Spp.), a Class I device regulated under 21 CFR 866.3375. Microbix Biosystems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 1985
- Date Received
- July 9, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigens, Cf, All, Mycoplasma Spp.
- Device Class
- Class I
- Regulation Number
- 866.3375
- Review Panel
- MI
- Submission Type