LDH Reagent Set
FDA 510(k) K812836 · Anco Medical Reagents & Assoc.
510(k) numberK812836
Submission
- Device name
- LDH Reagent Set
- Applicant
- Anco Medical Reagents & Assoc.
Mchenry, IL, US - Received
- October 9, 1981
- Decision date
- October 9, 1981
- Decision
- Unknown (SESP)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFH – Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1440
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CFH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050790 | Spotchem II LDH TestCFH · Traditional | Arkray, Inc. | 06/06/2005SE |
| K020484 | Careside LDHCFH · Traditional | Careside, Inc. | 07/03/2002SE |
| K895138 | Clinistat LDH Reagent TestCFH · Traditional | Heraeus Kulzer, Inc. | 10/19/1989SE |
| K894578 | Iq LDHCFH · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/17/1989SE |
| K880630 | Lactate Dehydrogenase (Ldh-L)CFH · Traditional | Tech-Co, Inc. | 03/16/1988SE |
| K860349 | Lactate Dehydrogenase (LDH) Reagent SetCFH · Traditional | Sterling Diagnostics, Inc. | 02/28/1986SE |
| K852391 | Edc/Titan Geliso-Dot Total LDH Isoenzyme ProcedureCFH · Traditional | Helena Laboratories | 10/01/1985SE |
| K842452 | Wako LDH Cii TestCFH · Traditional | Wako Chemicals USA, Inc. | 08/15/1984SE |
| K820768 | Colorimetric LDH Reagent SetCFH · Traditional | Biorent Diagnostic, Inc. | 04/14/1982SE |
| K782176 | Hycel Ldh-Int TestCFH · Traditional | Hycel, Inc. | 01/26/1979SE |
More from Hycel, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K842440 | Sickle Cell Stat A/S Heterozygous-ErythJPK · Traditional | 07/27/1984SE |
| K831871 | Sickle-Heme A/S Controls & A/A ControlGHM · Traditional | 07/28/1983SE |
| K821658 | Hemoglobin ReagentKHG · Traditional | 06/25/1982SE |
| K821526 | Acid Phosphatase Reagent SetCKE · Traditional | 06/10/1982SE |
| K821102 | Megnesium Reagent KitJGJ · Traditional | 05/05/1982SE |
| K820951 | Enzymatic Cholesterol KitCHH · Traditional | 04/26/1982SE |
| K820500 | Total Lipid Reagent SetCFD · Traditional | 03/11/1982SE |
| K820491 | SGPT Reagent SetCKD · Traditional | 03/11/1982SE |
| K820466 | Sgot Reagent SetCIQ · Traditional | 03/11/1982SE |
| K812837 | Alkaline Phosphatase Reagent SetCJL · Traditional | 01/29/1982SE |
Questions and answers
When was LDH Reagent Set cleared by the FDA?
LDH Reagent Set (K812836) received a 510(k) decision of Unknown on October 9, 1981, 0 days after the submission was received.
What is the product code of K812836?
The FDA product code is CFH – Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.