TOTAL IRON BINDING CAPACITY (TIBC)— 510(k) K880546
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K880546 for TOTAL IRON BINDING CAPACITY (TIBC), Substantially Equivalent on 1988-03-24. Applicant: Boehringer Mannheim Corp.. Device class: 1.
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- 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
- Indianapolis, IN, 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 Boehringer Mannheim Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.