Cleared Traditional

ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)

K881894 · Cambridge Bioscience Corp. · Microbiology
Jul 1988
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K881894 is an FDA 510(k) clearance for the ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48), a Antigens, Cf (including Cf Control), Adenovirus 1-33 (Class I — General Controls, product code GOD), submitted by Cambridge Bioscience Corp. (Worcester, US). The FDA issued a Cleared decision on July 8, 1988, 64 days after receiving the submission on May 5, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3020.

Submission Details

510(k) Number K881894 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1988
Decision Date July 08, 1988
Days to Decision 64 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GOD — Antigens, Cf (including Cf Control), Adenovirus 1-33
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3020

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