510(k) K981263
K981263 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "TOXOGEN". The FDA issued a decision of Substantially Equivalent on August 6, 1998. The device falls under product code GMM (Antigens, Iha, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 1998
- Date Received
- April 7, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigens, Iha, Toxoplasma Gondii
- Device Class
- Class II
- Regulation Number
- 866.3780
- Review Panel
- MI
- Submission Type