510(k) K861122
K861122 is an FDA 510(k) premarket notification submitted by Microbiological Research Corp. for the device "THE GOLDEN QUAD TEST (TOXO)". The FDA issued a decision of Substantially Equivalent on February 2, 1987. The device falls under product code LJK (Antisera, If, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Microbiological Research Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 1987
- Date Received
- March 25, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, If, Toxoplasma Gondii
- Device Class
- Class II
- Regulation Number
- 866.3780
- Review Panel
- MI
- Submission Type