UROL-GUANT— 510(k) K852295

Substantially Equivalent

Dimension Diagnostics

FDA 510(k) clearance K852295 for UROL-GUANT, Substantially Equivalent on 1985-07-22. Applicant: Dimension Diagnostics. Device class: 1.

Clearance details

Applicant: Dimension Diagnostics
Product code: Code JJW
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1985-05-29
Decision date: 1985-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Charles, MO, US

Download summary PDF View on FDA.gov ↗

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More clearances from Dimension Diagnostics

K863223 — DIMENSION-WBG1987-03-10
K861366 — ALT-30, 60 AND 1001986-06-25
K854967 — CRITIC - SF, ASSAYED1986-01-07
K853943 — CRITIC C LEVEL I & II1985-12-23
K844848 — IMA-TROL IMMUNOASSAY CONTROL1985-03-01

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