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510(k) K860679

IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN by Orion Corp. — Product Code DCN

Clearance Details

Decision
SN ()
Decision Date
August 4, 1986
Date Received
February 25, 1986
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 Orion Corp.

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  • K881505 — MAMEX DC MG11 (June 10, 1988)
  • K874040 — MAMEX DC S SL10/MG14 (November 23, 1987)
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  • K864457 — CHLAMYSET ANTIBODY EIA (September 11, 1987)
  • K872301 — DENTOCULT-SM CULTURE-PADDLE (September 11, 1987)

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