Product code CFH— Clinical Chemistry
CARESIDE LDH
- Classification name
- Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
- Device class
- Class 2
- Regulation
- 21 CFR 862.1440
- Advisory panel
- Clinical Chemistry
- Total cleared
- 13
- First cleared
- Most recent
Market context for product code CFH
FDA has cleared devices under product code CFH between 1976 and 2005, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2005
- 2002
- 1989
- 1988
- 1986
- 1985
- 1984
- 1982
- 1981
- 1979
- 1977
- 1976
Top applicants under product code CFH
Recent clearances under product code CFH
- K050790 — SPOTCHEM II LDH TEST
- K020484 — CARESIDE LDH
- K895138 — CLINISTAT LDH REAGENT TEST
- K894578 — IQ LDH
- K880630 — LACTATE DEHYDROGENASE (LDH-L)
- K860349 — LACTATE DEHYDROGENASE (LDH) REAGENT SET
- K852391 — EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
- K842452 — WAKO LDH CII TEST
- K820768 — COLORIMETRIC LDH REAGENT SET
- K812836 — LDH REAGENT SET
- K782176 — HYCEL LDH-INT TEST
- K771343 — LDH-INT TEST
- K760009 — COLORIMETRIC DETERMINATION (LDH)
Data sourced from openFDA. This site is unofficial and independent of the FDA.