QUICK-TELL INDIRECT PREGNANCY TEST— 510(k) K832640
Substantially EquivalentStanbio Laboratory
FDA 510(k) clearance K832640 for QUICK-TELL INDIRECT PREGNANCY TEST, Substantially Equivalent on 1983-10-04. Applicant: Stanbio Laboratory. Device class: 2.
Clearance details
- Applicant
- Stanbio Laboratory
- Product code
- Code JHJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JHJ
view allMore clearances from Stanbio Laboratory
view all- K090093 — STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM
- K081719 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
- K050266 — DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
- K050283 — CREATININE LIQUICOLOR
- K042169 — STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.