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

Pipette, Sahli

21 CFR 864.6160 / Hematology
FDA source (opens on fda.gov)

GGX is the FDA product code for Pipette, Sahli, a class I device type, regulated under 21 CFR 864.6160. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GGX
Device name
Pipette, Sahli
Regulation
21 CFR 864.6160
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
0

Clearances, product code GGX

By decision year
2 clearances under product code GGX with a decision year between 1989 and 1990, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GGX by decision year
YearClearances
19891
19901

Applicants with the most clearances

Product code GGX
Applicants holding the most 510(k) clearances under product code GGX
ApplicantClearances
Catachem, Inc.1
Trimedyne, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code