ULTRACHEM URIC ACID AIDH— 510(k) K821872

Substantially Equivalent

Harleco Diagnostics

FDA 510(k) clearance K821872 for ULTRACHEM URIC ACID AIDH, Substantially Equivalent on 1982-07-14. Applicant: Harleco Diagnostics. Device class: 1.

Clearance details

Applicant: Harleco Diagnostics
Product code: Code CDO
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1982-06-25
Decision date: 1982-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDO

K033278 — RANDOX URIC ACID2004-02-27
K992798 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P1999-09-28
K982251 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT1998-08-18
K981766 — URIC ACID1998-06-19
K981189 — URIC ACID1998-05-07

More clearances from Harleco Diagnostics

K823147 — URIC ACID STANDARD, 8MG/DL #650781982-11-22
K822852 — TRIGLYCERIDE CALIBRATOR1982-10-27
K822323 — ULTRACHEM BUN-UV, 65080 & 650811982-09-02
K821871 — ULTRAZYME PLUS 2GT1982-07-14
K821873 — ULTRACHEM T-BILI1982-07-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.