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

Tubes, Vacuum Sample, With Anticoagulant

21 CFR 862.1675 / Clinical Chemistry
FDA source (opens on fda.gov)

GIM is the FDA product code for Tubes, Vacuum Sample, With Anticoagulant, a class II device type, regulated under 21 CFR 862.1675. As of , FDA records hold 39 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
GIM
Device name
Tubes, Vacuum Sample, With Anticoagulant
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
39
Ingested recalls
9

Clearances, product code GIM

By decision year
39 clearances under product code GIM with a decision year between 1976 and 2024, 1977 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code GIM by decision year
YearClearances
19762
19779
19791
19801
19811
19861
19881
19902
19927
19931
19943
19952
19972
20011
20081
20171
20232
20241

Applicants with the most clearances

Product code GIM
Applicants holding the most 510(k) clearances under product code GIM
ApplicantClearances
Sherwood Medical Industries5
BD Becton Dickinson Vacutainer Systems Preanalytic3
Becton Dickinson & Co3
Jelco Laboratories3
Sherwood Medical Co.3
Becton Dickinson Vacutainer Systems2
Mbo Laboratories, Inc.2
Organon LLC2
Abbott Medical1
Caltag Medsystems Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order