DETECTADOT SYSTEM 2000 HETEROPHILE TEST— 510(k) K895891
Substantially EquivalentGull Laboratories, Inc.
FDA 510(k) clearance K895891 for DETECTADOT SYSTEM 2000 HETEROPHILE TEST, Substantially Equivalent on 1989-10-31. Applicant: Gull Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Gull Laboratories, Inc.
- Product code
- Code KTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5640
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code KTN
view allMore clearances from Gull Laboratories, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.