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510(k) K830611

RA SCREENING TEST by Tago, Inc. — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1983
Date Received
February 28, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type

Other clearances by Tago, Inc.

  • K841734 — TAGO FIFFU-GEN, OROSOMUCOID (June 1, 1984)
  • K841265 — TAGO DIFFU-GEN C-REACTIVE PROTEIN (May 22, 1984)
  • K834218 — DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - (May 11, 1984)
  • K840404 — DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO (March 9, 1984)
  • K833129 — TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 (November 21, 1983)
  • K830531 — MONO SCREENING TEST (March 17, 1983)
  • K830156 — HCG SCREENING TEST (February 9, 1983)

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