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

Thermometer, Clinical Mercury

21 CFR 880.2920 / General Hospital
FDA source (opens on fda.gov)

FLK is the FDA product code for Thermometer, Clinical Mercury, a class II device type, regulated under 21 CFR 880.2920. As of , FDA records hold 33 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FLK
Device name
Thermometer, Clinical Mercury
Regulation
21 CFR 880.2920
Device class
Class II
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
33
Ingested recalls
0

Clearances, product code FLK

By decision year
33 clearances under product code FLK with a decision year between 1976 and 1996, 1990 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code FLK by decision year
YearClearances
19761
19771
19784
19791
19802
19813
19821
19851
19871
19881
19891
19905
19912
19931
19944
19952
19962

Applicants with the most clearances

Product code FLK
Applicants holding the most 510(k) clearances under product code FLK
ApplicantClearances
Abco Dealers, Inc.3
Abel Industries, Inc.1
Airlife, Inc.1
Amg Medical Inc.1
Amsia Intl., Inc.1
Broadwest Corp.1
Chesebrough-Pond'S U.S.A. Co.1
Coltemp, Inc.1
Cypress Medical Products LLC1
Hospitak, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order