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

Control, Red-Cell

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

GJR is the FDA product code for Control, Red-Cell, a class II device type, regulated under 21 CFR 864.8625. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GJR
Device name
Control, Red-Cell
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
5
Ingested recalls
0

Clearances, product code GJR

By decision year
5 clearances under product code GJR with a decision year between 1990 and 2008, 1990 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GJR by decision year
YearClearances
19901
19951
20001
20061
20081

Applicants with the most clearances

Product code GJR
Applicants holding the most 510(k) clearances under product code GJR
ApplicantClearances
Streck LLC2
Streck Laboratories, Inc.2
Medical Specialties Intl., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code