510(k) K010582
K010582 is an FDA 510(k) premarket notification submitted by Acon Laboratories Co. for the device "ACON STREP A RAPID TEST STRIP". The FDA issued a decision of Substantially Equivalent on May 7, 2001. The device falls under product code GTY (Antigens, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Acon Laboratories Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 2001
- Date Received
- February 27, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigens, All Groups, Streptococcus Spp.
- Device Class
- Class I
- Regulation Number
- 866.3740
- Review Panel
- MI
- Submission Type