510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970830Substantially Equivalent

Remel Levofloxacin 5G Susceptibilty Disk

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

K970830 is the FDA 510(k) clearance record for REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK, a class II device, cleared for Remel, Inc. on under FDA product code JTN (Susceptibility Test Discs, Antimicrobial). FDA records list 107 510(k) clearances for Remel, Inc., from to . As of , FDA records show no recalls naming K970830.

Clearance record

Decision date
Received
(26 days to decision)
Product code
JTN Susceptibility Test Discs, Antimicrobial
Regulation
21 CFR 866.1620
Device class
Class II
Review panel
Microbiology
Applicant
Remel, Inc. 12076 Santa Fe Dr., Lenexa KS
510(k) summary
Statement
Third party review
No

Clearances, product code JTN

Trailing 12 months
6 clearances under product code JTN in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JTN, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20262
August 20261
September 20260
October 20260