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

Romanowsky Stains

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

GJL is the FDA product code for Romanowsky Stains, 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 no recalls.

Classification record

Product code
GJL
Device name
Romanowsky Stains
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
0

Clearances, product code GJL

By decision year
1 clearance under product code GJL with a decision year between 1988 and 1988, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GJL by decision year
YearClearances
19881

Applicants with the most clearances

Product code GJL
Applicants holding the most 510(k) clearances under product code GJL
ApplicantClearances
ELITechGroup Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code