Product code CFQ— Immunology
IMMUNOGLOBULIN A TEST SYSTEM
- Classification name
- Radioimmunoassay, Immunoglobulins (G, A, M)
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code CFQ
FDA has cleared devices under product code CFQ between 1988 and 1999, filed by 5 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
- 1999
- 1995
- 1989
- 1988
Top applicants under product code CFQ
Recent clearances under product code CFQ
- K981786 — IGA MININEPH ANTISERUM
- K990551 — IGG FLEX REAGENT CARTRIDGE
- K990552 — IMMUNOGLOBULIN A TEST SYSTEM
- K990553 — IGM FLEX REAGENT CARTRIDGE
- K951013 — OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT
- K951055 — OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT
- K950900 — OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT
- K891188 — TITAN GEL IFE TRIVALENT ANTISERUM
- K890561 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGM
- K881928 — MONOCLONAL RADIAL IMMUNODIFFUSION KIT
- K881827 — IMMUNOGLOBULIN A TEST SYSTEM
- K881828 — IMMUNOGLOBULIN M TEST SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.