Cleared Traditional

SAS ADENO TEST

K990630 · Sa Scientific, Inc. · Microbiology
Aug 1999
Decision
174d
Days
Class 1
Risk

About This 510(k) Submission

K990630 is an FDA 510(k) clearance for the SAS ADENO TEST, a Antigens, Cf (including Cf Control), Adenovirus 1-33 (Class I — General Controls, product code GOD), submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on August 19, 1999, 174 days after receiving the submission on February 26, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3020.

Submission Details

510(k) Number K990630 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1999
Decision Date August 19, 1999
Days to Decision 174 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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

Similar Devices — GOD Antigens, Cf (including Cf Control), Adenovirus 1-33

All 10
RPS ADENO DETECTOR PLUS
K110722 · Rapid Pathogen Screening, Inc. · May 2011
RPS ADENO DETECTOR
K052092 · Rapid Pathogen Screening · Nov 2005
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
K972406 · Immunoprobe, Inc. · Dec 1997
ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)
K881894 · Cambridge Bioscience Corp. · Jul 1988
ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST
K873082 · Cambridge Bioscience Corp. · Feb 1988
ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST
K873312 · Cambridge Bioscience Corp. · Feb 1988