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510(k) K832031

ANTI-N DNA ANTIBODY TEST KIT by Breit Laboratories, Inc. — Product Code KTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1983
Date Received
June 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Indirect Immunofluorescent Solid Phase
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Breit Laboratories, Inc.

  • K851099 — IGM RHEUMATOID FACTOR TEST KIT (April 25, 1985)
  • K840527 — COLOTRAK OCCULT BLOOD TEST (September 5, 1984)
  • K842137 — OCCULT BLOOD TEST (September 5, 1984)
  • K831927 — ANTINUCLEAR ANTIBODY TEST KIT (July 18, 1983)

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