Cryocheck la Sure, Model SUR25-10
FDA 510(k) K990580 · Precision Biologic
510(k) numberK990580
Submission
- Device name
- Cryocheck la Sure, Model SUR25-10
- Applicant
- Precision Biologic
Dartmouth, N.S., CA - Received
- February 23, 1999
- Decision date
- July 28, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K110031 | Hemosil Drvvt Screen & Hemosil Drvvt ConfirmGIR · Traditional | Instrumentation Laboratory CO | 08/24/2011SE |
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| 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 |
| 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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| K060284 | Cryocheck Clot ApcrGGW · Traditional | 05/10/2006SE |
| K043571 | Cryocheck Clot SGGP · Traditional | 03/18/2005SE |
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Questions and answers
When was Cryocheck la Sure, Model SUR25-10 cleared by the FDA?
Cryocheck la Sure, Model SUR25-10 (K990580) received a 510(k) decision of Substantially Equivalent on July 28, 1999, 155 days after the submission was received.
What is the product code of K990580?
The FDA product code is GIR – Reagent, Russel Viper Venom, a Class I (low risk) device regulated under 21 CFR 864.8950.