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

Control, Hematocrit

21 CFR 864.8625 / Hematology
FDA source (opens on fda.gov)

GLK is the FDA product code for Control, Hematocrit, a class II device type, regulated under 21 CFR 864.8625. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GLK
Device name
Control, Hematocrit
Regulation
21 CFR 864.8625
Device class
Class II
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
7
Ingested recalls
0

Clearances, product code GLK

By decision year
7 clearances under product code GLK with a decision year between 1989 and 2013, 2002 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GLK by decision year
YearClearances
19891
19931
19961
19971
20022
20131

Applicants with the most clearances

Product code GLK
Applicants holding the most 510(k) clearances under product code GLK
ApplicantClearances
Aalto Scientific Ltd.1
Bionostics, Inc.1
Ciba Corning Diagnostics Corp.1
Eurotrol B.V.1
Johnson & Johnson Professionals, Inc.1
Medical Specialties Inc.1
Richmond Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code