510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864205Substantially Equivalent

Thermonuclease Agar W/toluidine Blue

Remel Inc, Lenexa KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864205 is the FDA 510(k) clearance record for THERMONUCLEASE AGAR W/TOLUIDINE BLUE, a class I device, cleared for Remel Co. on under FDA product code JSH (Culture Media, Non-Selective And Differential). FDA records list 107 510(k) clearances for Remel Co., from to . As of , FDA records show no recalls naming K864205.

Clearance record

Decision date
Received
(28 days to decision)
Product code
JSH Culture Media, Non-Selective And Differential
Regulation
21 CFR 866.2320
Device class
Class I
Review panel
Microbiology
Applicant
Remel Co. 12076 Santa Fe Dr., Lenexa KS
Third party review
No

Clearances, product code JSH

Trailing 12 months

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

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