510(k) K904268
K904268 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.". The FDA issued a decision of Substantially Equivalent on November 13, 1990. The device falls under product code MDK (Dna-Probe, Reagents, Streptococcal), a Class I device regulated under 21 CFR 866.3740. Gen-Probe, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 1990
- Date Received
- September 18, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna-Probe, Reagents, Streptococcal
- Device Class
- Class I
- Regulation Number
- 866.3740
- Review Panel
- MI
- Submission Type