Lactate Dehydrogenase
FDA 510(k) K964912 · Derma Media Lab., Inc.
510(k) numberK964912
Submission
- Device name
- Lactate Dehydrogenase
- Applicant
- Derma Media Lab., Inc.
Santa Fe Springs, CA, US - Received
- December 9, 1996
- Decision date
- January 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|---|
| K131975 | Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace Ldh-L…CFJ · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 10/02/2013SE |
| K091544 | S-Test Lactate Dehydrogenase (LD), Model RC 0017CFJ · Traditional | Alfa Wassermann, Inc. | 09/09/2009SE |
| K051108 | Piccolo Lactate Dephydrogenase Test SystemCFJ · Traditional | Abaxis, Inc. | 07/08/2005SE |
| 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 |
| 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 |
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| K971309 | UreaCDQ · Traditional | 08/01/1997SE |
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| K971072 | Cholesterol ReagentCHH · Traditional | 06/20/1997SE |
| K971005 | TriglyceridesJGY · Traditional | 04/21/1997SE |
| K970867 | Uric Acid ReagentKNK · Traditional | 04/21/1997SE |
| K964915 | MagnesiumJGJ · Traditional | 03/26/1997SE |
| K964913 | Iron ReagentJIY · Traditional | 02/20/1997SE |
| K965134 | Alt/SgptCKA · Traditional | 02/18/1997SE |
| K964914 | Alkaline PhosphataseCJE · Traditional | 02/04/1997SE |
| K965126 | Ast/SgotCIT · Traditional | 01/17/1997SE |
Questions and answers
When was Lactate Dehydrogenase cleared by the FDA?
Lactate Dehydrogenase (K964912) received a 510(k) decision of Substantially Equivalent on January 9, 1997, 31 days after the submission was received.
What is the product code of K964912?
The FDA product code is CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.