510(k) K981485
K981485 is an FDA 510(k) premarket notification submitted by Digene Corp. for the device "HYBRID CAPTURE II GC-ID". The FDA issued a decision of Substantially Equivalent on Nov 29, 1999. The device falls under product code LSL (Dna-Reagents, Neisseria), a Class II device regulated under 21 CFR 866.3390. Digene Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 29, 1999
- Date Received
- Apr 24, 1998
- 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