510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
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K092819Substantially Equivalent

Remel Spectra Vre

Thermo Fisher Scientific Oy, Lenexa KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092819 is the FDA 510(k) clearance record for REMEL SPECTRA VRE, a class II device, cleared for Thermo Fisher Scientific on under FDA product code JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar). FDA records list 65 510(k) clearances for Thermo Fisher Scientific, from to . As of , FDA records show no recalls naming K092819.

Clearance record

Decision date
Received
(304 days to decision)
Product code
JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Regulation
21 CFR 866.1700
Device class
Class II
Review panel
Microbiology
Applicant
Thermo Fisher Scientific 12150 Santa Fe Dr., Lenexa KS
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JSO

Trailing 12 months

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

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