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

Reagent & Control, Partial Thromboplastin Time

21 CFR 864.7925 / Hematology
FDA source (opens on fda.gov)

GIT is the FDA product code for Reagent & Control, Partial Thromboplastin Time, a class II device type, regulated under 21 CFR 864.7925. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GIT
Device name
Reagent & Control, Partial Thromboplastin Time
Regulation
21 CFR 864.7925
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
0

Clearances, product code GIT

By decision year
4 clearances under product code GIT with a decision year between 1982 and 1989, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GIT by decision year
YearClearances
19821
19882
19891

Applicants with the most clearances

Product code GIT
Applicants holding the most 510(k) clearances under product code GIT
ApplicantClearances
Biotrack, Inc.1
Creative Laboratory Products, Inc.1
bioMerieux, Inc.1
Pacific Hemostasis1

Companies listing this code with FDA

Companies whose registered establishments list this code