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

Mixer, Blood Tube

21 CFR 862.2050 / Clinical Chemistry
FDA source (opens on fda.gov)

GLE is the FDA product code for Mixer, Blood Tube, a class I device type, regulated under 21 CFR 862.2050. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GLE
Device name
Mixer, Blood Tube
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code GLE

By decision year
5 clearances under product code GLE with a decision year between 1977 and 1982, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GLE by decision year
YearClearances
19772
19781
19801
19821

Applicants with the most clearances

Product code GLE
Applicants holding the most 510(k) clearances under product code GLE
ApplicantClearances
Cortex Research Corp.1
Helmer Labs, Inc.1
Innovative Medical Systems, Inc.1
Techhnilab Instruments, Inc.1
Thermolyne Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order