Accuclot Drvvt Confirm, Catalog No. A62119
FDA 510(k) K000528 · Sigma Diagnostics, Inc.
510(k) numberK000528
Submission
- Device name
- Accuclot Drvvt Confirm, Catalog No. A62119
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- February 17, 2000
- Decision date
- April 7, 2000
- 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
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| 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 |
| K110031 | Hemosil Drvvt Screen & Hemosil Drvvt ConfirmGIR · Traditional | Instrumentation Laboratory CO | 08/24/2011SE |
| 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 |
| 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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| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | 02/06/2002SE |
| K013549 | Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971DAP · Traditional | 12/26/2001SE |
| K013545 | Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221DAP · Traditional | 11/15/2001SE |
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| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | 10/26/2001SE |
| K010652 | Sigma Diagnostics Sigma-Cal, Model S2936JIX · Traditional | 03/30/2001SE |
| K010158 | Thrombomax-Hs with Calcium, Model T6540GGO · Traditional | 03/22/2001SE |
| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | 03/01/2001SE |
Questions and answers
When was Accuclot Drvvt Confirm, Catalog No. A62119 cleared by the FDA?
Accuclot Drvvt Confirm, Catalog No. A62119 (K000528) received a 510(k) decision of Substantially Equivalent on April 7, 2000, 50 days after the submission was received.
What is the product code of K000528?
The FDA product code is GIR – Reagent, Russel Viper Venom, a Class I (low risk) device regulated under 21 CFR 864.8950.