Cleared Traditional

FASTTAKE ADAPTER, MODEL # P/N 020-072-01

K983468 · Selfcare, Inc. · Chemistry
Dec 1998
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K983468 is an FDA 510(k) clearance for the FASTTAKE ADAPTER, MODEL # P/N 020-072-01, a Calculator/data Processing Module, For Clinical Use (Class I — General Controls, product code JQP), submitted by Selfcare, Inc. (Waltham, US). The FDA issued a Cleared decision on December 17, 1998, 77 days after receiving the submission on October 1, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2100.

Submission Details

510(k) Number K983468 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1998
Decision Date December 17, 1998
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JQP — Calculator/data Processing Module, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2100

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