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

Tube, Sedimentation Rate

21 CFR 864.6700 / Hematology
FDA source (opens on fda.gov)

GHC is the FDA product code for Tube, Sedimentation Rate, a class I device type, regulated under 21 CFR 864.6700. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
GHC
Device name
Tube, Sedimentation Rate
Regulation
21 CFR 864.6700
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
1
Ingested recalls
1

Clearances, product code GHC

By decision year
1 clearance under product code GHC with a decision year between 1989 and 1989, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GHC by decision year
YearClearances
19891

Applicants with the most clearances

Product code GHC
Applicants holding the most 510(k) clearances under product code GHC
ApplicantClearances
Investigacion Farmaceutica S.A. de C.V.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order