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510(k) K900338

VISUWELL(R) REAGIN TEST (MODIFICATION) by Adi Diagnostics, Inc. — Product Code GMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1990
Date Received
January 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Nontreponemal, All
Device Class
Class II
Regulation Number
866.3820
Review Panel
MI
Submission Type

Other clearances by Adi Diagnostics, Inc.

  • K910487 — VISUWELL SYPHILIS ANTIGEN (June 24, 1991)
  • K900973 — VISUWELL(R) CHLAMYDIA (May 15, 1990)
  • K890840 — VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT (March 27, 1989)

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