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

Control, Platelet

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

GJP is the FDA product code for Control, Platelet, a class II device type, regulated under 21 CFR 864.8625. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GJP
Device name
Control, Platelet
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
4
Ingested recalls
0

Clearances, product code GJP

By decision year
4 clearances under product code GJP with a decision year between 1977 and 1988, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GJP by decision year
YearClearances
19772
19831
19881

Applicants with the most clearances

Product code GJP
Applicants holding the most 510(k) clearances under product code GJP
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic1
Dade, Baxter Travenol Diagnostics, Inc.1
Fisher Scientific Company L.L.C.1
Medical Specialties Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code