HOME ACCESS HEPATITIS C TEST SERVICE

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Premarket Approval P980046 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a reduction of a supplement testing range (str) from specimens with a signal-to-cutoff value from 5. 0 to 4. 2.

DeviceHOME ACCESS HEPATITIS C TEST SERVICE
Classification NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Generic NameAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
ApplicantHOME ACCESS HEALTH CORP.
Date Received2002-10-24
Decision Date2002-12-06
PMAP980046
SupplementS005
Product CodeMZO
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address HOME ACCESS HEALTH CORP. 2401 W. Hassell suite 1510 hoffman Estates, IL 60195-5200

Supplemental Filings

Supplement NumberDateSupplement Type
P980046Original Filing
S009 2015-09-22 Normal 180 Day Track
S008 2011-08-01 30-day Notice
S007 2004-12-03 30-day Notice
S006 2003-05-28 Normal 180 Day Track No User Fee
S005 2002-10-24 Normal 180 Day Track
S004 2001-02-23 Normal 180 Day Track
S003
S002 2000-03-23 30-day Notice
S001

NIH GUDID Devices

Device IDPMASupp
M769HCV271 P980046 008
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