Data / Medical devices / United States / DSRV, Inc.
DSRV, Inc.: FDA-registered device maker in Mount Olive, NJ, United States, 5 510(k) clearances
DSRV, Inc. is registered with the FDA (registration 3004737529) in Mount Olive, NJ, United States. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 10, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004737529
- Address
- 330 Waterloo Valley Rd Suite 200, Mount Olive, NJ, United States, 07828
- Owner or operator
- DSRV INC (9002901)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 2, 2006
- Registered through
- 2026
- Brand names listed
- ExpertCor Routine, Frozen Format LA Confirm, Frozen Format LA Screen, GradiPlasma LA High, GradiPlasma LA Low, LA Confirm, LA Screen, STA Cleaner Solution (00973) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Control, Plasma, Abnormal | GGC | 2 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Contract manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls Unassayed | OHQ | 1 | Manufacturer | accessdata.fda.gov |
| Reagent, Russel Viper Venom | GIR | 1 | Manufacturer | accessdata.fda.gov |
| Test, Qualitative And Quantitative Factor Deficiency | GGP | 2 | Contract manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 10, 2014 | K132130 | REAGENT, RUSSEL VIPER VENOM - LA SCREEN | GIR | Substantially Equivalent | Dsrv, Inc. | accessdata.fda.gov |
| January 10, 2014 | K132076 | REAGENT, RUSSEL VIPER VENOM - LA CONFIRM | GIR | Substantially Equivalent | Dsrv, Inc. | accessdata.fda.gov |
| February 16, 2000 | K993332 | GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 | GGC | Substantially Equivalent | Gradipore , Ltd. | accessdata.fda.gov |
| April 6, 1993 | K922326 | LUPO-TEST REGEANT | GIR | Substantially Equivalent | Graoipore , Ltd. | accessdata.fda.gov |
| April 6, 1993 | K922156 | LUCOR CONFIRMATORY REAGENT | GIR | Substantially Equivalent | Gradipore , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Reagent, Russel Viper Venom
- All makers of Control, Plasma, Abnormal
- All makers of Test, Qualitative And Quantitative Factor Deficiency
- All makers of General Purpose Reagent
- All makers of Multi-Analyte Controls Unassayed
Updated January 10, 2014. 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.