CREATININE REAGENT SET— 510(k) K855193

Substantially Equivalent

Technostics Intl.

FDA 510(k) clearance K855193 for CREATININE REAGENT SET, Substantially Equivalent on 1986-01-14. Applicant: Technostics Intl.. Device class: 2.

Clearance details

Applicant: Technostics Intl.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1985-12-26
Decision date: 1986-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGX

K252206 — Nova Allegro UACR Assay, Nova Allegro Analyzer2026-01-09
K251058 — Tru Kidney Health Test Panel; Tru Analyzer2025-11-26
K242685 — Atellica® CH Creatinine_3 (Crea3)2024-12-04
K221813 — Nova Allegro UACR Assay, Nova Allegro Analyzer2024-11-19
K210452 — Creatinine22022-03-22

More clearances from Technostics Intl.

K855188 — CPK (UV) REAGENT KIT1986-03-05
K860111 — URIC ACID REAGENT SET1986-02-19
K855190 — MAGNESIUM REAGENT SET1986-02-18
K860110 — GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET1986-02-11
K860109 — ENZYMATIC UREA NITROGEN REAGENT SET1986-02-06

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