Il Test Lac Screen (Claims Added to Acl Futura), Il Test Lac Confirm (Claims Addad to Acl Futura)
FDA 510(k) K990302 · Instrumentation Laboratory CO
510(k) numberK990302
Submission
- Device name
- Il Test Lac Screen (Claims Added to Acl Futura), Il Test Lac Confirm (Claims Addad to Acl Futura)
- Applicant
- Instrumentation Laboratory CO
Lexington, MA, US - Received
- February 1, 1999
- Decision date
- April 8, 1999
- 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
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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 |
| 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 |
| K940490 | DV Test and DVV ConfirmGIR · Traditional | American Diagnostica, Inc. | 04/05/1995SE |
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| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | 08/10/2023SE |
| K223187 | HemosIL Liquid Anti-XaQLU · Traditional | 06/23/2023SE |
| 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 |
| K213464 | HemosIL Liquid Anti-XaKFF · Special | 10/04/2022SE |
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Questions and answers
When was Il Test Lac Screen (Claims Added to Acl Futura), Il Test Lac Confirm (Claims Addad to Acl Futura) cleared by the FDA?
Il Test Lac Screen (Claims Added to Acl Futura), Il Test Lac Confirm (Claims Addad to Acl Futura) (K990302) received a 510(k) decision of Substantially Equivalent on April 8, 1999, 66 days after the submission was received.
What is the product code of K990302?
The FDA product code is GIR – Reagent, Russel Viper Venom, a Class I (low risk) device regulated under 21 CFR 864.8950.