Ld-L Reagent
FDA 510(k) K971398 · Carolina Liquid Chemistries Corp.
510(k) numberK971398
Submission
- Device name
- Ld-L Reagent
- Applicant
- Carolina Liquid Chemistries Corp.
Brea, CA, US - Received
- April 15, 1997
- Decision date
- May 2, 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 |
| 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 |
|---|---|---|
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM)…DIO · Traditional | 01/27/2022SE |
| K163570 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)DIO · Traditional | 08/15/2017SE |
| K133519 | Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries…JJE · Traditional | 05/16/2014SE |
| K132711 | Carolina Liquid Chemistries HDL Cholesterol ReagentLBS · Traditional | 05/08/2014SE |
| K972073 | Total Bilirubin ReagentCIG · Traditional | 06/24/1997SE |
| K971907 | Calcium ReagentCIC · Traditional | 06/24/1997SE |
| K971324 | Triglycerides, TG, or TrigCDT · Traditional | 06/20/1997SE |
| K971967 | BunCDQ · Traditional | 06/17/1997SE |
| K971908 | Crea or CreatinineCGX · Traditional | 06/17/1997SE |
| K971467 | Synchron CX Systems Glucose Reagent (Glu)CFR · Traditional | 06/16/1997SE |
Questions and answers
When was Ld-L Reagent cleared by the FDA?
Ld-L Reagent (K971398) received a 510(k) decision of Substantially Equivalent on May 2, 1997, 17 days after the submission was received.
What is the product code of K971398?
The FDA product code is CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.