510(k) K802427
K802427 is an FDA 510(k) premarket notification submitted by Immuno-Mycologics, Inc. for the device "LA-SPORO ANTIBODY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code GMA (Antisera, Fluorescent, Sporothrix Schenekii), a Class I device regulated under 21 CFR 866.3680. Immuno-Mycologics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1980
- Date Received
- October 6, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, Sporothrix Schenekii
- Device Class
- Class I
- Regulation Number
- 866.3680
- Review Panel
- MI
- Submission Type