Cleared Traditional

ACE PHENOBARBITAL REAGENT/AED CALIBRATORS

K973536 · Schiapparelli Biosystems, Inc. · Chemistry
Nov 1997
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K973536 is an FDA 510(k) clearance for the ACE PHENOBARBITAL REAGENT/AED CALIBRATORS, a Calibrators, Drug Specific (Class II — Special Controls, product code DLJ), submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on November 6, 1997, 49 days after receiving the submission on September 18, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K973536 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 1997
Decision Date November 06, 1997
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DLJ — Calibrators, Drug Specific
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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