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

Stain, Reticulocyte

21 CFR 864.1850 / Hematology
FDA source (opens on fda.gov)

GJH is the FDA product code for Stain, Reticulocyte, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
GJH
Device name
Stain, Reticulocyte
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
1
Ingested recalls
1

Clearances, product code GJH

By decision year
1 clearance under product code GJH with a decision year between 1979 and 1979, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GJH by decision year
YearClearances
19791

Applicants with the most clearances

Product code GJH
Applicants holding the most 510(k) clearances under product code GJH
ApplicantClearances
Geometric Data, Div. Smithkline Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order