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510(k) K973457

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

K973457 is an FDA 510(k) premarket notification submitted by Shared Systems, Inc. for the device "CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800". The FDA issued a decision of Substantially Equivalent on January 2, 1998. The device falls under product code GMZ (Antigens, All Types, Escherichia Coli), a Class I device regulated under 21 CFR 866.3255. Shared Systems, Inc. has at least 4 other 510(k) clearances on record.

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)

Other clearances for product code GMZ

  • K222829 — Curian® Shiga Toxin (April 17, 2023)
  • K121411 — SHIGA TOXIN CHEK (October 2, 2012)
  • K121364 — SHIGA TOXIN QUIK CHEK (October 2, 2012)
  • 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)

FDA data resources