Careside LDH
FDA 510(k) K020484 · Careside, Inc.
510(k) numberK020484
Submission
- Device name
- Careside LDH
- Applicant
- Careside, Inc.
Culver City, CA, US - Received
- February 13, 2002
- Decision date
- July 3, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| 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 |
|---|---|---|
| K020486 | Careside GGTJPZ · Traditional | 07/01/2002SE |
| K020487 | Careside AltCKA · Traditional | 06/04/2002SE |
| K020488 | Careside TrglycerideCDT · Traditional | 04/15/2002SE |
| K002792 | Careside CholinesteraseDIH · Traditional | 11/08/2000SE |
| K001462 | Careside HemoglobinKHG · Traditional | 08/21/2000SE |
| K993771 | Careside Direct BilirubinCIG · Traditional | 12/27/1999SE |
| K993634 | Careside AnalyzerJJF · Traditional | 12/02/1999SE |
| K992475 | Careside CO2, TotalKHS · Traditional | 09/15/1999SE |
| K991717 | Careside MGJGJ · Traditional | 08/10/1999SE |
| K991371 | Careside AmmoniaJID · Traditional | 08/03/1999SE |
Questions and answers
When was Careside LDH cleared by the FDA?
Careside LDH (K020484) received a 510(k) decision of Substantially Equivalent on July 3, 2002, 140 days after the submission was received.
What is the product code of K020484?
The FDA product code is CFH – Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.