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510(k) K801961

RF-II TEST KIT by Immuno-Diagnostic Products, Inc. — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
August 19, 1980
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 Immuno-Diagnostic Products, Inc.

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  • K811022 — ANA TEST KIT (April 23, 1981)
  • K801959 — FTA-ABS TEST (October 23, 1980)
  • K801963 — CMV TEST KIT (October 23, 1980)
  • K801960 — ANTI-DS/N-DNA TEST KIT (October 10, 1980)

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