510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GIAClass I

Test, Leukocyte Peroxidase

21 CFR 864.7675 / Hematology
FDA source (opens on fda.gov)

GIA is the FDA product code for Test, Leukocyte Peroxidase, a class I device type, regulated under 21 CFR 864.7675. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GIA
Device name
Test, Leukocyte Peroxidase
Regulation
21 CFR 864.7675
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code GIA

By decision year
3 clearances under product code GIA with a decision year between 1981 and 1994, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GIA by decision year
YearClearances
19811
19851
19941

Applicants with the most clearances

Product code GIA
Applicants holding the most 510(k) clearances under product code GIA
ApplicantClearances
Sigma Chemical Co.2
Techlab, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code