Data / Medical devices / United States / Biochemical Diagnostics, Inc.
Biochemical Diagnostics, Inc.: FDA-registered device maker in Edgewood, NY, United States, 5 510(k) clearances
Biochemical Diagnostics, Inc. is registered with the FDA (registration 2432495) in Edgewood, NY, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 23, 2016. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2432495
- Address
- 180 Heartland BLVD., Edgewood, NY, United States, 11717
- Owner or operator
- BIOCHEMICAL DIAGNOSTICS, INC. (2432495)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- November 1, 2007
- Registered through
- 2026
- Brand names listed
- AU NZ SKREEN23, AU/NZ SKREEN, AU/NZ SKREEN23, DETECTABUSE, DOA-SKREEN, DOA-SKREEN-H, Detectabuse, Detectabuse Liquid Control and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drug Mixture Control Materials | DIF | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Multi-Analyte Controls Unassayed | OHQ | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2016 | K153474 | Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series | DIF | Substantially Equivalent | Biochemical Diagnostics, Inc. | accessdata.fda.gov |
| December 16, 2013 | K132688 | SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ | DIF | Substantially Equivalent | Biochemical Diagnostics, Inc. | accessdata.fda.gov |
| July 3, 2012 | K121122 | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL | DIF | Substantially Equivalent | Biochemical Diagnostic, Inc. | accessdata.fda.gov |
| March 29, 2005 | K050328 | PREGNANCY-SKREEN | JJX | Substantially Equivalent | Biochemical Diagnostic, Inc. | accessdata.fda.gov |
| December 28, 1992 | K925586 | DETECTABUSE(TM) | DIF | Substantially Equivalent | Biochemical Diagnostic, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 14, 2015 | 72197 | Class III | Terminated | CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatograp | CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert. | accessdata.fda.gov |
Compare with other makers
- All makers of Drug Mixture Control Materials
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Multi-Analyte Controls Unassayed
Updated February 23, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.