510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920974Substantially Equivalent

Bactidrop Acridine Orange

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

K920974 is the FDA 510(k) clearance record for BACTIDROP ACRIDINE ORANGE, a class II device, cleared for Remel Co. on under FDA product code JFO (Fluorometric, Calcium). FDA records list 107 510(k) clearances for Remel Co., from to . As of , FDA records show one recall naming K920974.

Clearance record

Decision date
Received
(109 days to decision)
Product code
JFO Fluorometric, Calcium
Regulation
21 CFR 862.1145
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Remel Co. 12076 Santa Fe Dr., Lenexa KS
510(k) summary
Statement
Third party review
No

Clearances, product code JFO

Trailing 12 months

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

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