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

Device, Automated Sedimentation Rate

21 CFR 864.5800 / Hematology
FDA source (opens on fda.gov)

GKB is the FDA product code for Device, Automated Sedimentation Rate, a class I device type, regulated under 21 CFR 864.5800. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
GKB
Device name
Device, Automated Sedimentation Rate
Regulation
21 CFR 864.5800
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
2
Ingested recalls
3

Clearances, product code GKB

By decision year
2 clearances under product code GKB with a decision year between 1989 and 1989, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GKB by decision year
YearClearances
19892

Applicants with the most clearances

Product code GKB
Applicants holding the most 510(k) clearances under product code GKB
ApplicantClearances
Gespac, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order