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510(k) K851099

IGM RHEUMATOID FACTOR TEST KIT by Breit Laboratories, Inc. — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1985
Date Received
March 19, 1985
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 Breit Laboratories, Inc.

  • K840527 — COLOTRAK OCCULT BLOOD TEST (September 5, 1984)
  • K842137 — OCCULT BLOOD TEST (September 5, 1984)
  • K832031 — ANTI-N DNA ANTIBODY TEST KIT (August 11, 1983)
  • K831927 — ANTINUCLEAR ANTIBODY TEST KIT (July 18, 1983)

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