GENTAMICIN FLEX REAGENT CARTRIDGE— 510(k) K962819

Clearance details

Applicant

Dade Intl., Inc.

Product code

Code LCD

Device class

Class 2

Regulation

21 CFR 862.3450

Advisory panel

Clinical Toxicology

Date received

1996-07-19

Decision date

1996-09-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Newark, DE, US

• K243500 — ARCHITECT iGentamicin2025-07-09
• K102699 — ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS2011-04-01
• K060709 — MULTIGENT GENTAMICIN2006-06-15
• K042479 — VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 142005-01-06
• K020704 — ROCHE ONLINE GENTAMICIN2002-07-12

• K974343 — DADE INNOVIN1998-07-22
• K970505 — DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/1997-11-17
• K973974 — DADE TRU-LIQUID CARDIAC CONTROL1997-11-06
• K973668 — CARDIAC TROPONIN-I (TROP) CALIBRATOR1997-10-20
• K972524 — DRIED GRAM-POSITIVE MIC/COMBO PANELS1997-09-08

• Z-2181-2018 — Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20180419
• Z-2182-2018 — Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20180419

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962819.