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510(k) K972156

QUIX RAPID E. COLI O157 STRIP TEST by Guardian Scientific, Corp. — Product Code GMZ

K972156 is an FDA 510(k) premarket notification submitted by Guardian Scientific, Corp. for the device "QUIX RAPID E. COLI O157 STRIP TEST". The FDA issued a decision of Substantially Equivalent on October 16, 1997. The device falls under product code GMZ (Antigens, All Types, Escherichia Coli), a Class I device regulated under 21 CFR 866.3255. Guardian Scientific, Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1997
Date Received
June 9, 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 Guardian Scientific, Corp.

  • K954994 — TRUST (October 18, 1996)
  • K954995 — QUIX RAPID CHOLERA STRIP TEST (August 15, 1996)
  • K954993 — QUIX RAPID PREGNANCY STRIP TEST (December 13, 1995)

Other clearances for product code GMZ

  • K222829 — Curian® Shiga Toxin (April 17, 2023)
  • K121364 — SHIGA TOXIN QUIK CHEK (October 2, 2012)
  • K121411 — SHIGA TOXIN 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)
  • K973457 — CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 (January 2, 1998)
  • K971663 — WELLCOLEX E.COLI O157:H7 (December 30, 1997)

FDA data resources