Hemosil Drvvt Screen & Hemosil Drvvt Confirm
FDA 510(k) K110031 · Instrumentation Laboratory CO
510(k) numberK110031
Submission
- Device name
- Hemosil Drvvt Screen & Hemosil Drvvt Confirm
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- January 5, 2011
- Decision date
- August 24, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GIR – Reagent, Russel Viper Venom
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8950
- Specialty
- Hematology
Other 510(k)s with product code GIR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132130 | Reagent, Russel Viper Venom - la ScreenGIR · Special | Dsrv, Inc. | 01/10/2014SE |
| K132076 | Reagent, Russel Viper Venom - la ConfirmGIR · Special | Dsrv, Inc. | 01/10/2014SE |
| K083878 | Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon laGIR · Traditional | R2 Diagnostics, Inc. | 06/25/2010SE |
| K061805 | Sta - Staclot DRVV Screen; Sta - Staclot DRVV ConfirmGIR · Traditional | Diagnostica Stago, Inc. | 12/06/2006SE |
| K000528 | Accuclot Drvvt Confirm, Catalog No. A62119GIR · Traditional | Sigma Diagnostics, Inc. | 04/07/2000SE |
| K000527 | Accuclot Drvvt Screen, Catalog No. A6094GIR · Traditional | Sigma Diagnostics, Inc. | 04/07/2000SE |
| K990580 | Cryocheck la Sure, Model SUR25-10GIR · Traditional | Precision Biologic | 07/28/1999SE |
| K990579 | Cryocheck la Check, Models CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)GIR · Traditional | Precision Biologic | 07/23/1999SE |
| K990302 | Il Test Lac Screen (Claims Added to Acl Futura), Il Test Lac Confirm (Claims Addad to…GIR · Traditional | Instrumentation Laboratory CO | 04/08/1999SE |
| K940490 | DV Test and DVV ConfirmGIR · Traditional | American Diagnostica, Inc. | 04/05/1995SE |
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| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | 06/21/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
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Questions and answers
When was Hemosil Drvvt Screen & Hemosil Drvvt Confirm cleared by the FDA?
Hemosil Drvvt Screen & Hemosil Drvvt Confirm (K110031) received a 510(k) decision of Substantially Equivalent on August 24, 2011, 231 days after the submission was received.
What is the product code of K110031?
The FDA product code is GIR – Reagent, Russel Viper Venom, a Class I (low risk) device regulated under 21 CFR 864.8950.