MULTISTAT III UREA NITROGEN TEST— 510(k) K771442
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K771442 for MULTISTAT III UREA NITROGEN TEST, Substantially Equivalent on 1977-08-22. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code CDN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CDN
view all- K190326 — VITROS XT Chemistry Products UREA-CREA Slides
- K132462 — S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
- K123322 — ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
- K113389 — ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
- K103615 — ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
More clearances from Instrumentation Laboratory CO
view allData sourced from openFDA. This site is unofficial and independent of the FDA.