510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033360Substantially Equivalent

Diazyme Lithium Enzymatic Assay Kit

General Atomics, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033360 is the FDA 510(k) clearance record for DIAZYME LITHIUM ENZYMATIC ASSAY KIT, a class II device, cleared for General Atomics on under FDA product code JII (Atomic Absorption, Lithium). FDA records list 6 510(k) clearances for General Atomics, from to . As of , FDA records show no recalls naming K033360.

Clearance record

Decision date
Received
(63 days to decision)
Product code
JII Atomic Absorption, Lithium
Regulation
21 CFR 862.3560
Device class
Class II
Review panel
Clinical Toxicology
Applicant
General Atomics 3550 General Atomics Ct., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JII

Trailing 12 months

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

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