Diazyme D-Dimer Assay Kit,Calibrator Setand Control Set
FDA 510(k) K112120 · Diazyme Laboratories
510(k) numberK112120
Submission
- Device name
- Diazyme D-Dimer Assay Kit,Calibrator Setand Control Set
- Applicant
- Diazyme Laboratories
Poway, CA, US - Received
- July 25, 2011
- Decision date
- January 24, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GHH – Fibrin Split Products
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7320
- Specialty
- Hematology
Other 510(k)s with product code GHH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072288 | Pathfast D-DimerGHH · Traditional | Mitsubishi Kagaku Iatron | 05/06/2009SE |
| K070453 | Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033…GHH · Traditional | Olympus Life & Material Science Europa GmbH (Irish | 06/11/2007SE |
| K062203 | Tina-Quant D-Dimer Test SystemGHH · Traditional | Roche Diagnostics Corp. | 03/14/2007SE |
| K042890 | Triage D-Dimer Test, Model 98100GHH · Traditional | Biosite Incorporated | 11/29/2004SE |
| K030740 | Modification to Tina-Quant D-Dimer Test SystemGHH · Special | Roche Diagnostics Corp. | 04/01/2003SE |
| K021877 | Mda D-DimerGHH · Traditional | bioMerieux, Inc. | 08/07/2002SE |
| K011143 | Tina-Quant D-Dimer Test SystemGHH · Special | Roche Diagnostics Corp. | 05/29/2001SE |
| K993276 | Simplify D-Dimer, Model DCGK1GHH · Traditional | Agen Biomedical , Ltd. | 12/14/1999SE |
| K972316 | Opus D-DimerGHH · Traditional | Behring Diagnostics, Inc. | 09/09/1997SE |
| K945642 | Agen Dimertest Gold EiaGHH · Traditional | Agen Biomedical , Ltd. | 10/25/1995SE |
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Questions and answers
When was Diazyme D-Dimer Assay Kit,Calibrator Setand Control Set cleared by the FDA?
Diazyme D-Dimer Assay Kit,Calibrator Setand Control Set (K112120) received a 510(k) decision of Substantially Equivalent on January 24, 2013, 549 days after the submission was received.
What is the product code of K112120?
The FDA product code is GHH – Fibrin Split Products, a Class II (moderate risk) device regulated under 21 CFR 864.7320.