510(k) K840012
K840012 is an FDA 510(k) premarket notification submitted by Zeus Technologies for the device "INDIRECT FLUORESCENT ANTIBODY MYCO". The FDA issued a decision of Substantially Equivalent on February 27, 1984. The device falls under product code GRZ (Antisera, Fluorescent, All, Mycoplasma Spp.), a Class I device regulated under 21 CFR 866.3375. Zeus Technologies has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1984
- Date Received
- January 4, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, All, Mycoplasma Spp.
- Device Class
- Class I
- Regulation Number
- 866.3375
- Review Panel
- MI
- Submission Type