Wako LDH Cii Test
FDA 510(k) K842452 · Wako Chemicals USA, Inc.
510(k) numberK842452
Submission
- Device name
- Wako LDH Cii Test
- Applicant
- Wako Chemicals USA, Inc.
Mchenry, IL, US - Received
- June 22, 1984
- Decision date
- August 15, 1984
- 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 |
| 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 |
|---|---|---|
| K100464 | Utaswako I30 (Includes Accessories), Utaswako AFP-L3, Calibrator Set, Control L, Control…NSF · Traditional | 02/23/2011SE |
| K080125 | Apolowako T-Cho, Hdl-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and…LBS · Traditional | 07/18/2008SE |
| K080123 | Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201CFR · Traditional | 07/17/2008SE |
| K061775 | Wako L-Type Creatinine-M Test, and Wako Creatinine CalibratorJFY · Traditional | 02/23/2007SE |
| K062368 | Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP…OAU · Traditional | 01/31/2007SE |
| K053132 | Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791JFM · Traditional | 12/30/2005SE |
| K053131 | Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191JFM · Traditional | 12/30/2005SE |
| K042551 | Multi-Chem Calibrator aJIX · Traditional | 11/16/2004SE |
| K042550 | Multi-Lipid CalibratorJIX · Traditional | 11/08/2004SE |
| K042549 | Multi Chem Cal BJIX · Traditional | 11/08/2004SE |
Questions and answers
When was Wako LDH Cii Test cleared by the FDA?
Wako LDH Cii Test (K842452) received a 510(k) decision of Substantially Equivalent on August 15, 1984, 54 days after the submission was received.
What is the product code of K842452?
The FDA product code is CFH – Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.