Cleared Traditional

SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346

K020625 · Helena Laboratories · Chemistry
May 2002
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K020625 is an FDA 510(k) clearance for the SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346, a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II — Special Controls, product code CIN), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on May 6, 2002, 69 days after receiving the submission on February 26, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K020625 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2002
Decision Date May 06, 2002
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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