Beckman Instruments, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469, ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
281
Total
281
Cleared
0
Denied
FDA 510(k) Regulatory Record - Beckman Instruments, Inc. Immunology ✕
59 devices
Cleared
May 01, 1998
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
Immunology
17d
Cleared
Feb 20, 1998
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
Immunology
59d
Cleared
Feb 17, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
Immunology
74d
Cleared
Nov 24, 1997
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT
Immunology
31d
Cleared
Nov 20, 1997
IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT
Immunology
44d
Cleared
Aug 20, 1997
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT
Immunology
84d
Cleared
Jun 27, 1997
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
Immunology
57d
Cleared
Jun 11, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
Immunology
190d
Cleared
Jun 03, 1997
SYNCHRON SYSTEMS CAL 5 PLUS
Immunology
57d
Cleared
Jun 03, 1997
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF...
Immunology
20d
Cleared
May 09, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT
Immunology
163d
Cleared
Apr 29, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
Immunology
158d
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