510(k) K910886— QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK
Substantially EquivalentKallestad Diag, A Div. of Erbamont, Inc.
Clearance details
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
- Product code
- Code GTQ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.