510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913005Substantially Equivalent

Bactidrop(tm) Lactophenol Aniline Blue

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

K913005 is the FDA 510(k) clearance record for BACTIDROP(TM) LACTOPHENOL ANILINE BLUE, a class II device, cleared for Remel Co. on under FDA product code JIO (Blood, Occult, Colorimetric, In Urine). FDA records list 107 510(k) clearances for Remel Co., from to . As of , FDA records show no recalls naming K913005.

Clearance record

Decision date
Received
(70 days to decision)
Product code
JIO Blood, Occult, Colorimetric, In Urine
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
Remel Co. 12076 Santa Fe Dr., Lenexa KS
510(k) summary
Statement
Third party review
No

Clearances, product code JIO

Trailing 12 months

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

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