Ldh-P (Lactic Dehydrogenase) Reagent
FDA 510(k) K860729 · Trace Scientific , Ltd.
510(k) numberK860729
Submission
- Device name
- Ldh-P (Lactic Dehydrogenase) Reagent
- Applicant
- Trace Scientific , Ltd.
Clayton, Vic 3168, AU - Received
- February 26, 1986
- Decision date
- April 7, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
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| K961123 | Alt Incorporating DSTCKA · Traditional | 04/25/1996SE |
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| K932713 | Trace Transferrin ReagentDDQ · Traditional | 09/30/1993SE |
| K923322 | Trace Albumin-Mr ReagentCIX · Traditional | 09/11/1992SE |
| K914731 | Trace Gamma Gt-Ss ReagentJQB · Traditional | 11/19/1991SE |
| K911866 | Trace Total/Direct Bilirubin ReagentCIG · Traditional | 07/17/1991SE |
Questions and answers
When was Ldh-P (Lactic Dehydrogenase) Reagent cleared by the FDA?
Ldh-P (Lactic Dehydrogenase) Reagent (K860729) received a 510(k) decision of Substantially Equivalent on April 7, 1986, 40 days after the submission was received.
What is the product code of K860729?
The FDA product code is CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.