Piccolo Lactate Dephydrogenase Test System
FDA 510(k) K051108 · Abaxis, Inc.
510(k) numberK051108
Submission
- Device name
- Piccolo Lactate Dephydrogenase Test System
- Applicant
- Abaxis, Inc.
Union City, CA, US - Received
- May 2, 2005
- Decision date
- July 8, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1440
- Specialty
- Clinical Chemistry
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|---|---|---|---|
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| K091544 | S-Test Lactate Dehydrogenase (LD), Model RC 0017CFJ · Traditional | Alfa Wassermann, Inc. | 09/09/2009SE |
| K974859 | Lactane Dehydrogenase-Sl Assay, Catalogue Number 327-10, 327-30CFJ · Traditional | Diagnostic Chemicals , Ltd. | 01/22/1998SE |
| K973589 | Liquid Ldh-L Reagent SetCFJ · Traditional | Pointe Scientific, Inc., | 10/08/1997SE |
| K970684 | Lactate Dehydrogenase (LD)CFJ · Traditional | Randox Laboratories, Ltd. | 05/07/1997SE |
| K971398 | Ld-L ReagentCFJ · Traditional | Carolina Liquid Chemistries Corp. | 05/02/1997SE |
| K964912 | Lactate DehydrogenaseCFJ · Traditional | Derma Media Lab., Inc. | 01/09/1997SE |
| K961431 | Lactate Dehydrogenase Reagent SetCFJ · Traditional | Pointe Scientific, Inc., | 06/03/1996SE |
| K952747 | Lactate Dehydrogenase Reagent SystemCFJ · Traditional | Medical Diagnostic Technologies, Inc. | 08/07/1995SE |
| K946022 | Hichem Ldh/L Reagent KitCFJ · Traditional | Hichem Diagnostics | 02/23/1995SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K200865 | Piccolo Potassium Test SystemMZV · Dual Track | 10/20/2021SE |
| K130113 | Piccolo Lactate Test SystemKHP · Traditional | 03/11/2013SE |
| K130200 | Piccolo Total Cholesterol - Capillary Test SystemCHH · Traditional | 02/15/2013SE |
| K120664 | Piccolo Trglycerides-Capillary Test SystemJGY · Traditional | 04/24/2012SE |
| K120662 | Piccolo Hdl-Capillary Test SystemJHM · Traditional | 04/24/2012SE |
| K091052 | Piccolo C-Reactive Protein (CRP) Test SystemDCN · Traditional | 01/15/2010SE |
| K091910 | Piccolo Magnesium Test SystemJGJ · Special | 10/01/2009SE |
| K040115 | Piccolo Magnesium Test SystemJGJ · Traditional | 01/30/2004SE |
| K023642 | Piccolo Total Cholesterol Test SystemCHH · Traditional | 01/24/2003SE |
| K023640 | Piccolo HDL Test SystemLBS · Traditional | 01/24/2003SE |
Questions and answers
When was Piccolo Lactate Dephydrogenase Test System cleared by the FDA?
Piccolo Lactate Dephydrogenase Test System (K051108) received a 510(k) decision of Substantially Equivalent on July 8, 2005, 67 days after the submission was received.
What is the product code of K051108?
The FDA product code is CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.