Atlas FDA

STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.

FDA 510(k) clearance K895484 · decided 1989-10-04

Clearance details

K-number
K895484
Device name
STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1989-09-11
Decision date
1989-10-04
Days to decision
23 days
Clearance type
Traditional
Product code
LCD
Device class
2
Regulation number
862.3450
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Miami, FL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ARCHITECT iGentamicin (K243500)Abbott Laboratories2025-07-09
ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS (K102699)Abbott Laboratories2011-04-01
MULTIGENT GENTAMICIN (K060709)Seradyn, Inc.2006-06-15
VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE (K042479)Ortho-Clinical Diagnostics, Inc.2005-01-06
ROCHE ONLINE GENTAMICIN (K020704)Roche Diagnostics Corp.2002-07-12
RANDOX GENTAMICIN (K012978)Randox Laboratories, Ltd.2001-09-18
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) (K012311)Diagnostic Products Corp.2001-08-20
EMIT 2000 GENTAMICIN PLUS ASSAY (K010984)Syva Co., Dade Behring, Inc.2001-04-20
GENTAMICIN FLEX REAGENT CARTRIDGE (K962819)Dade Intl., Inc.1996-09-13
EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS (K962519)Behring Diagnostics, Inc.1996-09-04
ACS GENTAMICIN (K953020)Ciba Corning Diagnostics Corp.1995-08-02
IL TEST GENTAMICIN CALIBRATORS (K943982)Instrumentation Laboratory CO1995-01-25

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077)Baxter Healthcare Corp2025-11-13
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076)Baxter Healthcare Corp2025-06-30
Floseal Hemostatic Matrix (P990009/S075)Baxter Healthcare Corp2025-01-30
Adept Adhesion Reduction Solution (P050011/S009)Baxter Healthcare Corp2024-08-23
Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074)Baxter Healthcare Corp2024-08-15
Floseal Hemostatic Matrix (P990009/S073)Baxter Healthcare Corp2024-01-10
Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072)Baxter Healthcare Corp2023-12-12
Floseal Hemostatic Matrix, RT5 (P990009/S070)Baxter Healthcare Corp2023-02-02