GIA · Class I · 21 CFR 864.7675

FDA Product Code GIA: Test, Leukocyte Peroxidase

Leading manufacturers include Sigma Chemical Co. and Techlab, Inc..

3
Total
3
Cleared
137d
Avg days
1981
Since

FDA 510(k) Cleared Test, Leukocyte Peroxidase Devices (Product Code GIA)

3 devices
1–3 of 3
Cleared Feb 03, 1994
FAST'N'FLAMMATORY KIT
K931241
Techlab, Inc.
Hematology · 329d
Cleared Jan 04, 1985
SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR
K844402
Sigma Chemical Co.
Pathology · 52d
Cleared May 15, 1981
HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE
K811011
Sigma Chemical Co.
Toxicology · 30d

About Product Code GIA - Regulatory Context