Medical Device Manufacturer · US , Cockeysville , MD

Becton Dickinson Advanced Diagnostics

10 submissions · 10 cleared · Since 1991
10
Total
10
Cleared
0
Denied

Becton Dickinson Advanced Diagnostics — FDA 510(k) Submissions

Becton Dickinson Advanced Diagnostics has submitted 10 FDA 510(k) premarket notifications since 1991, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Visual, Pregnancy Hcg, Prescription Use, Radioassay, Triiodothyronine Uptake, Radioimmunoassay, Total Thyroxine, Antigens, All Groups, Streptococcus Spp., Multi-analyte Controls, All Kinds (assayed) . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
QTEST(R) STREP
K935667 · GTY Antigens, All Groups,... · Microbiology
Apr 1994 146d
IQ TUPTAKE ASSAY
K931294 · KHQ Radioassay,... · Chemistry
Jul 1993 129d
IQ TT4 ASSAY
K931295 · CDX Radioimmunoassay, Total... · Chemistry
Jul 1993 127d
PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG
K926356 · JHI Visual, Pregnancy Hcg,... · Chemistry
Mar 1993 87d
BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE
K925132 · JLW Radioimmunoassay,... · Chemistry
Dec 1992 76d
PRECISE STREP A
K923673 · GTZ Antisera, All Groups,... · Microbiology
Sep 1992 68d
IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY
K923060 · JJE Analyzer, Chemistry... · Chemistry
Sep 1992 82d
RIATRAC PLUS
K914958 · JJY Multi-analyte Controls,... · Chemistry
Mar 1992 134d
PRECISE TM HCG
K915197 · JHI Visual, Pregnancy Hcg,... · Chemistry
Dec 1991 28d
PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA
K915200 · JHI Visual, Pregnancy Hcg,... · Chemistry
Dec 1991 27d
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