510(k) K883486
K883486 is an FDA 510(k) premarket notification submitted by Technology Management & Marketing, Inc. for the device "GONOSTAT". The FDA issued a decision of Substantially Equivalent on August 15, 1989. The device falls under product code LSL (Dna-Reagents, Neisseria), a Class II device regulated under 21 CFR 866.3390. Technology Management & Marketing, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 1989
- Date Received
- August 16, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna-Reagents, Neisseria
- Device Class
- Class II
- Regulation Number
- 866.3390
- Review Panel
- MI
- Submission Type