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510(k) K904496

CROMATEST SYPHILIS DIAGNOSTIC by Biotrax, Inc. — Product Code GMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1991
Date Received
October 2, 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 Biotrax, Inc.

  • K904416 — CROATEST (R) RHEUMATOID DIAGNOSTIC (June 24, 1991)
  • K904497 — CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST (November 1, 1990)
  • K904498 — CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST (October 29, 1990)

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