Product code DAK— Immunology
ANTI-HUMAN CIQ SERUM
- Classification name
- Complement C1q, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5240
- Advisory panel
- Immunology
- Total cleared
- 28
- First cleared
- Most recent
Market context for product code DAK
FDA has cleared devices under product code DAK between 1977 and 2003, filed by 20 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
- 2003
- 2002
- 1998
- 1995
- 1991
- 1988
- 1987
- 1986
- 1985
- 1984
- 1982
- 1979
- 1978
- 1977
Top applicants under product code DAK
Recent clearances under product code DAK
- K031563 — BINDAZYME CLQ CIC EIA KIT
- K032254 — IBL C1Q-CIC CIA TEST
- K012576 — CIC-C1Q EIA
- K973203 — THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES
- K972873 — IMMUSTRIP HAMA IGG
- K951968 — HUMAN C1Q RADIAL IMMUNODIFFUSION KIT
- K914388 — C1 RID KIT
- K882829 — CIRCULATING IMMUNE COMPLEXES CONTROLS
- K860996 — SANASSAY IC TEST
- K864312 — IC MICROASSAY
- K862649 — CYTOTECH CIC ENZYME IMMUNOASSAY
- K861499 — BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT
- K853697 — BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT
- K851202 — GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL
- K844294 — CORDIA IC
- K833275 — GMP CIQ ELISA TEST KIT
- K833636 — ORTHO* SERUM ELISA TEST SYSTEM
- K841541 — SERUM COMPLEMENT ACTIVITY TEST-SCAT
- K823009 — GAMMA CLQ
- K821949 — ORTHO* ALTERNATIVE PATHWAY COMPL. TEST
- K821806 — ORTHO CLG IMMUNE COMPLEX TEST SYSTEM
- K792472 — ELECTRO-IMMUNO-QUANTITATION (EIQ)
- K781022 — ANTI-HUMAN CIQ SERUM
- K780729 — LAS-R HUMAN COMPLEMENT CLQ TEST
- K772114 — FIAX C4 ASSAY
- K772003 — HUMAN REFERENCE SERUM C4 COMPLEMENT
- K770964 — GOAT ANTISERUM COMPLEMENT C3 NEPHEL.
- K770547 — LAS-R TM HUMAN COMPLEMENT C4 TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.