TEKTALLY II— 510(k) K771580
Substantially EquivalentScientific Products
FDA 510(k) clearance K771580 for TEKTALLY II, Substantially Equivalent on 1977-09-02. Applicant: Scientific Products. Device class: 1.
Clearance details
- Applicant
- Scientific Products
- Product code
- Code GKM
- Device class
- Class 1
- Regulation
- 21 CFR 864.6160
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code GKM
view allData sourced from openFDA. This site is unofficial and independent of the FDA.