510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163571Substantially Equivalent

Great Basin Stool Bacterial Pathogens Panel

Great Basin Scientific, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163571 is the FDA 510(k) clearance record for Great Basin Stool Bacterial Pathogens Panel, a class II device, cleared for Great Basin Scientific, Inc. on under FDA product code PCI (Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System). FDA's definition for product code PCI reads: "A gastrointestinal bacterial panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool...". FDA records list 5 510(k) clearances for Great Basin Scientific, Inc., from to . As of , FDA records show no recalls naming K163571.

Clearance record

Decision date
Received
(205 days to decision)
Product code
PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
Regulation
21 CFR 866.3990
Device class
Class II
Review panel
Microbiology
Applicant
Great Basin Scientific, Inc. 2441 S. 3850 W., Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PCI

Trailing 12 months

FDA records hold no clearances under product code PCI in the trailing twelve months.

FDA records show no clearances under product code PCI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PCI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260