510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884720Substantially Equivalent

Germ Tube Solution

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

K884720 is the FDA 510(k) clearance record for GERM TUBE SOLUTION, a class I device, cleared for Remel Co. on under FDA product code JXC (Kit, Screening, Yeast). FDA records list 107 510(k) clearances for Remel Co., from to . As of , FDA records show no recalls naming K884720.

Clearance record

Decision date
Received
(204 days to decision)
Product code
JXC Kit, Screening, Yeast
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Remel Co. 12076 Santa Fe Dr., Lenexa KS
Third party review
No

Clearances, product code JXC

Trailing 12 months

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

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