510(k) K050790
- Device
- SPOTCHEM II LDH TEST
- Applicant
- ARKRAY, INC.
- 510(k) number
- K050790
- Product code
- CFH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-06-06
- Date received
- 2005-03-28
- Regulation
- 862.1440
- Classification name
- Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HELEN LANDICHO
- Address
- 510 Furnace Dock Rd. Cortlandt Manor NY US 10567 10567
FDA Registration Numbers#
- 3021841051
- 1832216
Source Documents#
Other 510(k) Records For Product Code CFH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K020484 | CARESIDE LDH | Careside, Inc. | 2002-07-03 |
| K895138 | CLINISTAT LDH REAGENT TEST | Heraeus Kulzer, Inc. | 1989-10-19 |
| K894578 | IQ LDH | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-17 |
| K880630 | LACTATE DEHYDROGENASE (LDH-L) | Tech-Co, Inc. | 1988-03-16 |
| K860349 | LACTATE DEHYDROGENASE (LDH) REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-28 |
| K852391 | EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE | Helena Laboratories | 1985-10-01 |
| K842452 | WAKO LDH CII TEST | Wako Chemicals USA, Inc. | 1984-08-15 |
| K820768 | COLORIMETRIC LDH REAGENT SET | Biorent Diagnostic, Inc. | 1982-04-14 |
| K812836 | LDH REAGENT SET | Anco Medical Reagents & Assoc. | 1981-10-09 |
| K782176 | HYCEL LDH-INT TEST | Hycel, Inc. | 1979-01-26 |
| K771343 | LDH-INT TEST | Hycel, Inc. | 1977-08-10 |
| K760009 | COLORIMETRIC DETERMINATION (LDH) | The Dow Chemical Co. | 1976-07-20 |
Legacy Summary#
summary
FDA Review#
Decision Summary