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510(k) K944421

E.COLI 0157 LATEX TEST by Pro-Lab Diagnostics — Product Code GMZ

K944421 is an FDA 510(k) premarket notification submitted by Pro-Lab Diagnostics for the device "E.COLI 0157 LATEX TEST". The FDA issued a decision of Substantially Equivalent on December 15, 1994. The device falls under product code GMZ (Antigens, All Types, Escherichia Coli), a Class I device regulated under 21 CFR 866.3255. Pro-Lab Diagnostics has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1994
Date Received
August 18, 1994
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 Pro-Lab Diagnostics

  • K924330 — TRANSYSTEM AMIES WITH CHARCOAL (December 24, 1992)
  • K924328 — TRANSYSTEM LIQUID AMIES MEDIUM (December 24, 1992)
  • K924331 — TRANSYSTEM LIQUID STUART MEDIUM (December 24, 1992)
  • K924329 — TRANSYSTEM AMIES W/O CHARCOAL (December 24, 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)
  • 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