510(k) K843664
K843664 is an FDA 510(k) premarket notification submitted by Institute Virion , Ltd. for the device "MYCOPLASMA PNEUMONIAE". The FDA issued a decision of Substantially Equivalent on October 25, 1984. The device falls under product code GSB (Antigens, Cf, All, Mycoplasma Spp.), a Class I device regulated under 21 CFR 866.3375. Institute Virion , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 1984
- Date Received
- September 17, 1984
- 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