Colorimetric LDH Reagent Set
FDA 510(k) K820768 · Biorent Diagnostic, Inc.
510(k) numberK820768
Submission
- Device name
- Colorimetric LDH Reagent Set
- Applicant
- Biorent Diagnostic, Inc.
Mchenry, IL, US - Received
- March 22, 1982
- Decision date
- April 14, 1982
- 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 |
| 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 |
| 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 |
|---|---|---|
| K832747 | Albumin Reagent SetCIX · Traditional | 10/14/1983SE |
| K823211 | Ck-Uv ReagentJHS · Traditional | 11/22/1982SE |
| K823060 | Hemoglobin ReagentKHG · Traditional | 11/22/1982SE |
| K822494 | Optimized Uv-Gpt Reagent SetCKA · Traditional | 09/21/1982SE |
| K822493 | Optimized Uv-Got Reagent SetCIT · Traditional | 09/21/1982SE |
| K822492 | Optimized Uv-Ldh Reagent SetCFJ · Traditional | 09/17/1982SE |
| K820632 | Colorimetric Uric Acid Reagent SetKNK · Traditional | 03/25/1982SE |
| K813555 | Glucose Enzyme-Color Reagent SetCGA · Traditional | 01/18/1982SE |
| K813244 | UV Uric Acid DeterminationCDO · Traditional | 12/08/1981SE |
| K811760 | Cholesterol DeterminationCHH · Traditional | 07/10/1981SE |
Questions and answers
When was Colorimetric LDH Reagent Set cleared by the FDA?
Colorimetric LDH Reagent Set (K820768) received a 510(k) decision of Substantially Equivalent on April 14, 1982, 23 days after the submission was received.
What is the product code of K820768?
The FDA product code is CFH – Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.