Atlas FDA

VISUWELL(R) REAGIN TEST (MODIFICATION)

FDA 510(k) clearance K900338 · decided 1990-04-10

Clearance details

K-number
K900338
Device name
VISUWELL(R) REAGIN TEST (MODIFICATION)
Applicant
Adi Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
1990-01-23
Decision date
1990-04-10
Days to decision
77 days
Clearance type
Traditional
Product code
GMQ
Device class
2
Regulation number
866.3820
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Rexdale, Ontario, CA
Third-party review
No
Expedited review
No

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THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST (K000687)Beacon Biologicals, Inc.2000-06-12
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AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI (K992124)Avanti Polar Lipids, Inc.1999-09-20
TRUST (K954994)Guardian Scientific, Corp.1996-10-18
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Recalls involving this device

No recalls on record reference this clearance.