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

Hematocrit, Tube, Rack, Sealer, Holder

21 CFR 864.6400 / Hematology
FDA source (opens on fda.gov)

GHY is the FDA product code for Hematocrit, Tube, Rack, Sealer, Holder, a class II device type, regulated under 21 CFR 864.6400. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GHY
Device name
Hematocrit, Tube, Rack, Sealer, Holder
Regulation
21 CFR 864.6400
Device class
Class II
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
0

Clearances, product code GHY

By decision year
2 clearances under product code GHY with a decision year between 1988 and 1988, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GHY by decision year
YearClearances
19882

Applicants with the most clearances

Product code GHY
Applicants holding the most 510(k) clearances under product code GHY
ApplicantClearances
Helps Products, Inc.1
Norfolk Scientific, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order