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510(k) K955042

CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM by Shared Systems, Inc. — Product Code DCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1995
Date Received
November 3, 1995
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 Shared Systems, Inc.

  • K973457 — CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 (January 2, 1998)
  • K950073 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM (October 17, 1995)
  • K953261 — CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM (August 15, 1995)
  • K920212 — MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM (August 20, 1992)

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