ULTRACHEM PHOS— 510(k) K821874

Substantially Equivalent

Harleco Diagnostics

FDA 510(k) clearance K821874 for ULTRACHEM PHOS, Substantially Equivalent on 1982-07-13. Applicant: Harleco Diagnostics. Device class: 1.

Clearance details

Applicant: Harleco Diagnostics
Product code: Code CEO
Device class: Class 1
Regulation: 21 CFR 862.1580
Advisory panel: Clinical Chemistry
Date received: 1982-06-25
Decision date: 1982-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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
K821872 — ULTRACHEM URIC ACID AIDH1982-07-14

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