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510(k) K834390

IMMUNO-CRP by Immunostics Co., Inc. — Product Code DCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1984
Date Received
December 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, C-Reactive Protein
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

Other clearances by Immunostics Co., Inc.

  • K926569 — IMMUNO RA UNDILUTED (April 6, 1993)
  • K902360 — HEMA-SCREEN (July 27, 1990)
  • K894780 — IMMUNO/ASO (October 16, 1989)
  • K883685 — IMMUNO/FEBRILE ANTIGENS (September 28, 1988)
  • K872910 — IMMUNO/SLE (August 12, 1987)
  • K863741 — IMMUNO-CEPT D (BETA-MONOCLONAL) (November 13, 1986)
  • K854619 — DETECTACULT (March 3, 1986)
  • K853105 — IMMUNO-IM (September 3, 1985)
  • K842110 — SLIDE PREGNANCY TEST (July 12, 1984)
  • K834391 — IMMUNO-RA (February 3, 1984)

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