Becton Dickinson Advanced Diagnostics
Cockeysville, MD, US
Becton Dickinson Advanced Diagnostics appears in FDA device records in Cockeysville, MD. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Becton Dickinson Advanced Diagnostics between 1991 and 1994. The busiest year on record is 1992, with 4. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 2 |
| 1992 | 4 |
| 1993 | 3 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K935667 | QTEST(R) STREP | GTY | Substantially Equivalent | |
| K931294 | IQ TUPTAKE ASSAY | KHQ | Substantially Equivalent | |
| K931295 | IQ TT4 ASSAY | CDX | Substantially Equivalent | |
| K926356 | PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG | JHI | Substantially Equivalent | |
| K925132 | BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE | JLW | Substantially Equivalent | |
| K923673 | PRECISE STREP A | GTZ | Substantially Equivalent | |
| K923060 | IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY | JJE | Substantially Equivalent | |
| K914958 | RIATRAC PLUS | JJY | Substantially Equivalent | |
| K915197 | PRECISE TM HCG | JHI | Substantially Equivalent | |
| K915200 | PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA | JHI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- GTYAntigens, All Groups, Streptococcus Spp.
- GTZAntisera, All Groups, Streptococcus Spp.
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- KHQRadioassay, Triiodothyronine Uptake
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain