ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01— 510(k) K913922
Substantially EquivalentEm Diagnostic Systems, Inc.
FDA 510(k) clearance K913922 for ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01, Substantially Equivalent on 1991-09-19. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Em Diagnostic Systems, Inc.
- Product code
- Code JMO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1415
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gibbstown, NJ, US
Recent devices under product code JMO
view all- K113438 — ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
- K061464 — VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668
- K052867 — VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
- K041793 — OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
- K013102 — WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002
More clearances from Em Diagnostic Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.