510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071188Substantially Equivalent

Modification to Jbaids Anthrax Detection System

Idaho Technology, Inc., Salt Lake City UT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071188 is the FDA 510(k) clearance record for MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM, a class II device, cleared for Idaho Technology, Inc. on under FDA product code NHT (Assay, Nucleic Acid Amplification, Bacillus Anthracis). FDA's definition for product code NHT reads: "An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth". FDA records list 8 510(k) clearances for Idaho Technology, Inc., from to . As of , FDA records show no recalls naming K071188.

Clearance record

Decision date
Received
(21 days to decision)
Product code
NHT Assay, Nucleic Acid Amplification, Bacillus Anthracis
Regulation
21 CFR 866.3045
Device class
Class II
Review panel
Microbiology
Applicant
Idaho Technology, Inc. 390 Wakara Way, Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHT

Trailing 12 months

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

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