Bio-Rad - FDA 510(k) Cleared Devices
319
Total
319
Cleared
0
Denied
319 devices
Cleared
Dec 19, 1994
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
Chemistry
405d
Cleared
Nov 10, 1994
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM
Chemistry
171d
Cleared
Jun 30, 1994
RADIAS ANA SCREEN ENZYME IMMUNOASSAY
Immunology
93d
Cleared
Jun 16, 1994
LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH
Hematology
42d
Cleared
Apr 06, 1994
RADIAS 3RD GENERATION TSH IMMUNOASSAY
Chemistry
161d
Cleared
Apr 05, 1994
RADIAS MONOCLONAL HBA 1C ASSAY
Hematology
134d
Cleared
Feb 18, 1994
QUANTAPHASE II B12/FOLATE
Chemistry
137d
Cleared
Oct 21, 1993
LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2
Chemistry
43d
Cleared
Oct 01, 1993
RADIAS FOLATE ENZYME IMMUNOASSAY
Chemistry
70d
Cleared
Sep 08, 1993
RADIAS FERRITIN ENZYME IMMUNOASSAY
Immunology
63d
Cleared
Aug 25, 1993
RADIAS B12 ENZYME IMMUNOASSAY
Chemistry
49d
Cleared
Aug 16, 1993
COTUBE ESTRADIOL RADIOIMMUNOASSAY
Chemistry
131d
Cleared
Aug 11, 1993
LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2
Chemistry
35d
Cleared
Aug 03, 1993
BIO-PEN SRK II CALCULATOR
Ophthalmic
427d
Cleared
Jul 08, 1993
LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL
Toxicology
36d
Cleared
Jun 29, 1993
LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II
Chemistry
61d
Cleared
Jun 22, 1993
TIP & MEMBRANE ASSEMBLY
Ophthalmic
483d
Cleared
Jun 16, 1993
RADIAS TSH ENZYME IMMUNOASSAY
Toxicology
107d
Cleared
May 20, 1993
RADIAS FREE T4 ENZYME IMMUNOASSAY
Chemistry
78d
Cleared
Apr 21, 1993
RADIAS AUTOMATED IMMUNOASSAY SYSTEM
Chemistry
58d
Cleared
Mar 29, 1993
VARIANT(TM) HEMOGLOBIN A 1C PROGRAM
Hematology
91d
Cleared
Mar 11, 1993
VARIANT BETA-THALASSEMIA SHORT PROGRAM
Hematology
209d
Cleared
Jan 14, 1993
VARIANT SICKLE CELL SHORT PROGRAM
Hematology
111d
Cleared
Dec 17, 1992
LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3
Chemistry
65d
Cleared
Oct 06, 1992
LIQUICHEK RHEUMATOID FACTOR CONTROL
Immunology
78d
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