510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN120013Unknown

Portrait Analyzer

Great Basin Scientific, Inc., Salt Lake City UT / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN120013 is the FDA 510(k) clearance record for PORTRAIT ANALYZER, a class I device, cleared for Great Basin Scientific on under FDA product code OMN (C. Difficile Nucleic Acid Amplification Test Assay). FDA's definition for product code OMN reads: "In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients". FDA records list 5 510(k) clearances for Great Basin Scientific, from to . As of , FDA records show no recalls naming DEN120013.

Clearance record

Decision date
Received
(59 days to decision)
Product code
OMN C. Difficile Nucleic Acid Amplification Test Assay
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Great Basin Scientific 2441 S. 3850 W., Salt Lake City UT
Third party review
No

Clearances, product code OMN

Trailing 12 months

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

FDA records show no clearances under product code OMN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OMN, 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