LDH (UV Kinetic)
FDA 510(k) K781128 · Macomb Chemical Co.
510(k) numberK781128
Submission
- Device name
- LDH (UV Kinetic)
- Applicant
- Macomb Chemical Co.
Mchenry, IL, US - Received
- June 30, 1978
- Decision date
- August 10, 1978
- 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
Other 510(k)s with product code CFJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K830095 | Rapid Chem Analyzer IIJJF · Traditional | 01/28/1983SE |
| K823720 | SpectrophotometerJJQ · Traditional | 01/07/1983SE |
| K810958 | GlycohemoglobinLCP · Traditional | 09/16/1981SE |
| K801086 | P-Nitrophenyl Phosphate · Traditional | 05/28/1980SE |
| K800719 | Enzymatic Urea Nitrogen Reagent Set ReviCDQ · Traditional | 05/08/1980SE |
| K800720 | Macomb Nad-Nicotinamide Adenine Dinucleo · Traditional | 04/21/1980SE |
| K792533 | Creatine Phosphokinase (CPK) Reagent SetJHW · Traditional | 01/11/1980SE |
| K792532 | Glucose (Hexokinase) Reagent SetCFR · Traditional | 01/11/1980SE |
| K791669 | Glucose Oxidase Reagent SetCGA · Traditional | 09/24/1979SE |
| K791511 | Enzymatic Reagent Set, 4X250 Ml.CHH · Traditional | 09/04/1979SE |
Questions and answers
When was LDH (UV Kinetic) cleared by the FDA?
LDH (UV Kinetic) (K781128) received a 510(k) decision of Substantially Equivalent on August 10, 1978, 41 days after the submission was received.
What is the product code of K781128?
The FDA product code is CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.