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

Mixture, Control, White-Cell And Red-Cell Indices

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

GLQ is the FDA product code for Mixture, Control, White-Cell And Red-Cell Indices, a class II device type, regulated under 21 CFR 864.8625. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GLQ
Device name
Mixture, Control, White-Cell And Red-Cell Indices
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
10
Ingested recalls
0

Clearances, product code GLQ

By decision year
10 clearances under product code GLQ with a decision year between 1982 and 2011, 1983 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GLQ by decision year
YearClearances
19821
19832
19991
20002
20091
20101
20112

Applicants with the most clearances

Product code GLQ
Applicants holding the most 510(k) clearances under product code GLQ
ApplicantClearances
Streck LLC4
Streck Laboratories, Inc.4
General Diagnostics1
Medical Specialties Laboratories1

Companies listing this code with FDA

Companies whose registered establishments list this code