Atlas FDA

ABUSCREEN(R) ONLINE CONTROLS

FDA 510(k) clearance K910689 · decided 1991-03-11

Clearance details

K-number
K910689
Device name
ABUSCREEN(R) ONLINE CONTROLS
Applicant
Roche Diagnostic Systems, Inc.
Decision
Substantially Equivalent
Date received
1991-02-19
Decision date
1991-03-11
Days to decision
20 days
Clearance type
Traditional
Product code
LAS
Device class
1
Regulation number
862.3280
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Montclair, NJ, US
Third-party review
No
Expedited review
No

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RecordFirmDate
CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS (K080459)Chromsystems Instruments & Chemicals GmbH2009-11-17
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QUANTIMETRIX NICOSURE COTININE URINE CONTROL (K062942)Quantimetrix Corp.2006-10-30
MAS IMMUNOSUPPRESSANT CONTROLS (K051074)Microgenics Corp.2005-06-06
DRI OXYCODONE ASSAY (K040411)Microgenics Corp.2004-05-27
MICROGENICS CYCLOSPORINE CONTROL KIT (K032842)Microgenics Corp.2003-10-17
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 (K030616)Microgenics Corp.2003-03-31
REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE (K992151)Consolidated Technologies, Inc.1999-07-14
INNOFLUOR TOPIRAMATE CONTROL SET (K970517)Oxis Intl., Inc.1997-05-12
SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS (K971210)Beckman Instruments, Inc.1997-04-17
ROCHE-TDM ONLEIN(TM) CONTROLS (K946119)Roche Diagnostic Systems, Inc.1995-02-07
MICROGENICS THC CONTROL SETS (K943048)Microgenics Corp.1994-08-24

Recalls involving this device

No recalls on record reference this clearance.