Lactate Dehydrogenase (LDH) Reagent Set
FDA 510(k) K860349 · Sterling Diagnostics, Inc.
510(k) numberK860349
Submission
- Device name
- Lactate Dehydrogenase (LDH) Reagent Set
- Applicant
- Sterling Diagnostics, Inc.
Sterling Heights, MI, US - Received
- January 30, 1986
- Decision date
- February 28, 1986
- Decision
- Substantially Equivalent (SESE)
- 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 |
| 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 |
| K812836 | LDH Reagent SetCFH · Traditional | Anco Medical Reagents & Assoc. | 10/09/1981SESP |
| K782176 | Hycel Ldh-Int TestCFH · Traditional | Hycel, Inc. | 01/26/1979SE |
More from Hycel, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921412 | Microprotein Reagent SetCEK · Traditional | 01/21/1993SE |
| K914609 | Triglycerides Reagent SetCDT · Traditional | 11/07/1991SE |
| K914039 | Sodium Reagent SetCEI · Traditional | 10/31/1991SE |
| K914040 | Phospholipid Reagent SetJNT · Traditional | 10/30/1991SE |
| K862255 | Lactate Dehydrogenase (LDH) Reagent Set (UV Rate)CFJ · Traditional | 07/29/1986SE |
| K861962 | Vanilmandelic Acid (Vma) Reagent SetCDF · Traditional | 07/07/1986SE |
| K862256 | Alkaline Phosphatase (PNPP Rate) Reagent SetCJE · Traditional | 07/01/1986SE |
| K862210 | Urea Nitrogen (GLDH) Reagent Set (UV)CDQ · Traditional | 07/01/1986SE |
| K862209 | Alt (SGPT) Reagent Set (UV Rate)CKA · Traditional | 06/25/1986SE |
| K861855 | Hydroxybutyrate Dehydrogenase (HBD) Reagent SetJKF · Traditional | 06/16/1986SE |
Questions and answers
When was Lactate Dehydrogenase (LDH) Reagent Set cleared by the FDA?
Lactate Dehydrogenase (LDH) Reagent Set (K860349) received a 510(k) decision of Substantially Equivalent on February 28, 1986, 29 days after the submission was received.
What is the product code of K860349?
The FDA product code is CFH – Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.