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

Spinner, Slide, Automated

21 CFR 864.5850 / Hematology
FDA source (opens on fda.gov)

GKJ is the FDA product code for Spinner, Slide, Automated, a class I device type, regulated under 21 CFR 864.5850. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GKJ
Device name
Spinner, Slide, Automated
Regulation
21 CFR 864.5850
Device class
Class I
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
6
Ingested recalls
1

Clearances, product code GKJ

By decision year
6 clearances under product code GKJ with a decision year between 1976 and 1985, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GKJ by decision year
YearClearances
19761
19771
19811
19831
19852

Applicants with the most clearances

Product code GKJ
Applicants holding the most 510(k) clearances under product code GKJ
ApplicantClearances
Geometric Data, Div. Smithkline Corp.2
Coulter Electronics, Inc.1
Dynatech Cryomedical Co.1
Prevo Micro-Mat System1
Ulster Scientific, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code