Lactate Dehydrogenase (Ldh-L)
FDA 510(k) K880630 · Tech-Co, Inc.
510(k) numberK880630
Submission
- Device name
- Lactate Dehydrogenase (Ldh-L)
- Applicant
- Tech-Co, Inc.
Oak Park, MI, US - Received
- February 16, 1988
- Decision date
- March 16, 1988
- 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 |
| 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 |
|---|---|---|
| K921968 | In Vitro Diagnostic Reagent Set, Indir. Preg. TestJHJ · Traditional | 06/28/1996SE |
| K923376 | Visual HCG Pregnancy TestJHI · Traditional | 10/01/1992SE |
| K920766 | T4 Eia Bead AssayCDX · Traditional | 04/17/1992SE |
| K920716 | Direct Pregnancy TestJHJ · Traditional | 03/24/1992SE |
| K902574 | Potassium Reagent SetCEJ · Traditional | 07/10/1990SE |
| K901561 | Iron/Total Iron Binding CapacityJIY · Traditional | 05/17/1990SE |
| K883387 | Alanine Amino Transferase (Colorimetric Method)CKD · Traditional | 10/13/1988SE |
| K883683 | HemoglobinGJZ · Traditional | 10/06/1988SE |
| K883386 | ChlorideCHJ · Traditional | 10/06/1988SE |
| K881173 | Aspartate Aminotransferase (Colorimetric Method)CIQ · Traditional | 06/07/1988SE |
Questions and answers
When was Lactate Dehydrogenase (Ldh-L) cleared by the FDA?
Lactate Dehydrogenase (Ldh-L) (K880630) received a 510(k) decision of Substantially Equivalent on March 16, 1988, 29 days after the submission was received.
What is the product code of K880630?
The FDA product code is CFH – Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.