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

Reagent, Platelet Aggregation

21 CFR 864.5700 / Hematology
FDA source (opens on fda.gov)

GHR is the FDA product code for Reagent, Platelet Aggregation, a class II device type, regulated under 21 CFR 864.5700. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
GHR
Device name
Reagent, Platelet Aggregation
Regulation
21 CFR 864.5700
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
11
Ingested recalls
2

Clearances, product code GHR

By decision year
11 clearances under product code GHR with a decision year between 1976 and 2007, 1991 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code GHR by decision year
YearClearances
19761
19821
19831
19901
19914
19921
19951
20071

Applicants with the most clearances

Product code GHR
Applicants holding the most 510(k) clearances under product code GHR
ApplicantClearances
Helena Laboratories, Corp.6
Chrono-Log Corp.3
Medical Diagnostic Technologies, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code