Cleared Traditional

AMYLASE

K812699 · Pointe Scientific, Inc., · Chemistry
Oct 1981
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K812699 is an FDA 510(k) clearance for the AMYLASE, a Nephelometric, Amylase (Class II — Special Controls, product code KHM), submitted by Pointe Scientific, Inc., (Mchenry, US). The FDA issued a Cleared decision on October 6, 1981, 14 days after receiving the submission on September 22, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K812699 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 1981
Decision Date October 06, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KHM — Nephelometric, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070