Lactic Dehydrogenase (VV) Reagent Set
FDA 510(k) K855157 · Technostics Intl.
510(k) numberK855157
Submission
- Device name
- Lactic Dehydrogenase (VV) Reagent Set
- Applicant
- Technostics Intl.
Washington, MI, US - Received
- December 26, 1985
- Decision date
- January 21, 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
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 |
|---|---|---|
| K855188 | CPK (UV) Reagent KitJHS · Traditional | 03/05/1986SE |
| K860111 | Uric Acid Reagent SetLFQ · Traditional | 02/19/1986SE |
| K855190 | Magnesium Reagent SetJGJ · Traditional | 02/18/1986SE |
| K860110 | Glutamic Pyruvic Transaminase, Gpt(Uv) Reagent SetCKA · Traditional | 02/11/1986SE |
| K860109 | Enzymatic Urea Nitrogen Reagent SetCDQ · Traditional | 02/06/1986SE |
| K860112 | Total Lipids Reagent SetCFD · Traditional | 01/24/1986SE |
| K855185 | Glucose Reagent SetCGE · Traditional | 01/22/1986SE |
| K855195 | Direct & Total Bilirubin SetCIG · Traditional | 01/14/1986SE |
| K855194 | Glucose Oxidase Reagent SetCGA · Traditional | 01/14/1986SE |
| K855193 | Creatinine Reagent SetCGX · Traditional | 01/14/1986SE |
Questions and answers
When was Lactic Dehydrogenase (VV) Reagent Set cleared by the FDA?
Lactic Dehydrogenase (VV) Reagent Set (K855157) received a 510(k) decision of Substantially Equivalent on January 21, 1986, 26 days after the submission was received.
What is the product code of K855157?
The FDA product code is CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.