510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945915Substantially Equivalent

Avl Omni Analyzer

Avl Scientific Corp., Roswell GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945915 is the FDA 510(k) clearance record for AVL OMNI ANALYZER, a class I device, cleared for Avl Scientific Corp. on under FDA product code JJC (Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use). FDA records list 33 510(k) clearances for Avl Scientific Corp., from to . As of , FDA records show 9 recalls naming K945915.

Clearance record

Decision date
Received
(124 days to decision)
Product code
JJC Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Regulation
21 CFR 862.2150
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Avl Scientific Corp. 33 Mansell Ct., Roswell GA
510(k) summary
Summary
Third party review
No

Clearances, product code JJC

Trailing 12 months

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

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