FMH · Class I · 21 CFR 864.3250

FDA Product Code FMH: Container, Specimen, Sterile

Leading manufacturers include Sage Products, Inc., C.R. Bard, Inc. and Sherwood Medical Co..

23
Total
23
Cleared
43d
Avg days
1976
Since

FDA 510(k) Cleared Container, Specimen, Sterile Devices (Product Code FMH)

23 devices
1–23 of 23
Cleared Jan 19, 1983
VARIOUS-SPECIMEN COLLECTORS
K823763
Cordis Corp.
General Hospital · 36d
Cleared Nov 06, 1981
LANCER SPECIMEN CONTAINER
K812933
Sherwood Medical Co.
General Hospital · 17d
Cleared Oct 10, 1980
SPECIMEN SET
K802340
American Pharmaseal Div. Ahsc
General Hospital · 14d
Cleared Sep 09, 1980
URINE SPECIMEN CONTAINER #'S 1013-1016
K802002
Pollak (Intl.), Ltd.
General Hospital · 20d
Cleared May 30, 1980
MIDSTREAM COLLECTION KIT
K800947
Sage Products, Inc.
General Hospital · 38d
Cleared Feb 26, 1980
ABCO MIDSTREAM URINE COLLECTION SET
K800233
Abco Dealers, Inc.
General Hospital · 21d
Cleared Feb 26, 1980
SPECIMEN COLLECTION PAN
K800309
Sage Products, Inc.
General Hospital · 14d
Cleared Jan 28, 1980
PARA-PAK CLEAN VIAL
K792710
Meridian Diagnostics, Inc.
General Hospital · 32d
Cleared Dec 10, 1979
LANCER SPECIMEN CONTAINER
K792156
Sherwood Medical Co.
General Hospital · 42d
Cleared Jun 27, 1979
JUHN TYM-TAP
K790915
Xomed, Inc.
General Hospital · 44d
Cleared Apr 10, 1979
OPERATING ROOM SPECIMEN CONTAINER
K790291
Sage Products, Inc.
General Hospital · 61d
Cleared Oct 17, 1978
24-HOUR URINE COLLECTION COOLING WRAP
K781557
Sage Products, Inc.
General Hospital · 36d
Cleared Feb 21, 1978
URINE SAMPLE COLLECTION KIT
K780057
C.R. Bard, Inc.
General Hospital · 42d
Cleared Feb 21, 1978
CATH KIT, URINE SPECIMEN
K780167
C.R. Bard, Inc.
General Hospital · 19d

About Product Code FMH - Regulatory Context