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510(k) K973457

CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 by Shared Systems, Inc. — Product Code GMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1998
Date Received
September 12, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All Types, Escherichia Coli
Device Class
Class I
Regulation Number
866.3255
Review Panel
MI
Submission Type

Other clearances by Shared Systems, Inc.

  • K955042 — CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM (December 13, 1995)
  • 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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  • K062546 — IMMUNOCARD STAT! EHEC, MODEL 751630 (February 14, 2007)
  • K061889 — BIOSTAR OIA SHIGATOX (December 12, 2006)
  • K023599 — IMMUNOCARD STAT! E. COLI O157 PLUS (January 3, 2003)
  • K990263 — IMMUNOCARD STAT! E. COLI O157:H7 (August 9, 1999)
  • K980507 — PROSPECT SHIGA TOXIN MICROPLATE ASSAY (April 23, 1998)
  • K971663 — WELLCOLEX E.COLI O157:H7 (December 30, 1997)
  • K972156 — QUIX RAPID E. COLI O157 STRIP TEST (October 16, 1997)