ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET— 510(k) K862256

Name: FDA 510(k) clearance K862256
Creator: U.S. Food and Drug Administration
Published: 1986-07-01

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K862256 for ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET, Substantially Equivalent on 1986-07-01. Applicant: Sterling Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1986-06-13
Decision date: 1986-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CJE

view all

K251074 — Tru Liver Health Test Panel2025-12-19
K240468 — Alkaline Phosphatase2024-10-16
K223317 — Alkaline Phosphatase22023-07-21
K191245 — Yumizen C1200 ALP, Yumizen C1200 Albumin2019-08-30
K171971 — Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer2018-01-25

More clearances from Sterling Diagnostics, Inc.

view all

K921412 — MICROPROTEIN REAGENT SET1993-01-21
K914609 — TRIGLYCERIDES REAGENT SET1991-11-07
K914039 — SODIUM REAGENT SET1991-10-31
K914040 — PHOSPHOLIPID REAGENT SET1991-10-30
K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)1986-07-29

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