CREATININE— 510(k) K830556

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K830556 for CREATININE, Substantially Equivalent on 1983-03-24. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1983-02-23
Decision date: 1983-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K221813 — Nova Allegro UACR Assay, Nova Allegro Analyzer2024-11-19
K210452 — Creatinine22022-03-22

More clearances from Pointe Scientific, Inc.,

K070757 — MICROPROTEIN REAGENT SET2007-12-04
K062118 — POINTE 3602007-07-13
K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT2007-04-30
K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR2007-04-13
K070504 — AMMONIA/ALCOHOL CONTROL SET2007-04-11

Recalls naming K830556

K-number listed on FDA's recall record

Z-2773-2015 — Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.Class III·Terminated·Pointe Scientific, Inc.·20141212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K830556.

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