510(k) K924715
K924715 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST". The FDA issued a decision of Substantially Equivalent on March 11, 1994. 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
- March 11, 1994
- Date Received
- September 21, 1992
- 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