Lactate Dehydrogenase Qvet
FDA 510(k) K942964 · Prisma Systems
510(k) numberK942964
Submission
- Device name
- Lactate Dehydrogenase Qvet
- Applicant
- Prisma Systems
Rome, NY, US - Received
- June 23, 1994
- Decision date
- December 29, 1994
- 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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|---|---|---|---|
| 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 |
More from Medical Diagnostic Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950177 | CK QvetCGS · Traditional | 03/03/1995SE |
| K943027 | Cholesterol QvetCHH · Traditional | 01/27/1995SE |
| K943042 | Bun QvetCDN · Traditional | 12/29/1994SE |
| K943001 | Magnesium QvetJGJ · Traditional | 12/29/1994SE |
| K942997 | Alkaline Phosphatase (Alkp) QvetCJE · Traditional | 12/29/1994SE |
| K942963 | Glucose QvetCFR · Traditional | 12/29/1994SE |
| K944102 | Ast QvetCIT · Traditional | 12/13/1994SE |
| K943000 | Albumin QvetCIX · Traditional | 12/13/1994SE |
| K943026 | Potassium QvetCEJ · Traditional | 12/09/1994SE |
| K943004 | Total Protein QvetCEK · Traditional | 12/09/1994SE |
Questions and answers
When was Lactate Dehydrogenase Qvet cleared by the FDA?
Lactate Dehydrogenase Qvet (K942964) received a 510(k) decision of Substantially Equivalent on December 29, 1994, 189 days after the submission was received.
What is the product code of K942964?
The FDA product code is CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.