Product code FMH

Device name: Container, Specimen, Sterile
Medical specialty: Pathology
Device class: 1
Regulation number: 864.3250
Review panel: HO
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K900983	TRI-TECH URINE SPECIMEN KIT	Tri-Tech, Inc.	1990-09-17
K823763	VARIOUS-SPECIMEN COLLECTORS	Cordis Corp.	1983-01-19
K820180	CALCULI FILTER CUP	Omnimedical	1982-02-05
K812933	LANCER SPECIMEN CONTAINER	Sherwood Medical Co.	1981-11-06
K802340	SPECIMEN SET	American Pharmaseal Div. Ahsc	1980-10-10
K802002	URINE SPECIMEN CONTAINER #'S 1013-1016	Pollak (Intl.), Ltd.	1980-09-09
K800947	MIDSTREAM COLLECTION KIT	Sage Products, Inc.	1980-05-30
K800309	SPECIMEN COLLECTION PAN	Sage Products, Inc.	1980-02-26
K800233	ABCO MIDSTREAM URINE COLLECTION SET	Abco Dealers, Inc.	1980-02-26
K792710	PARA-PAK CLEAN VIAL	Meridian Diagnostics, Inc.	1980-01-28
K792156	LANCER SPECIMEN CONTAINER	Sherwood Medical Co.	1979-12-10
K792211	SPECIMAN CUP & EMESIS BASIN	General Clinical Plastics Corp.	1979-11-16
K790915	JUHN TYM-TAP	Xomed, Inc.	1979-06-27
K790291	OPERATING ROOM SPECIMEN CONTAINER	Sage Products, Inc.	1979-04-10
K781557	24-HOUR URINE COLLECTION COOLING WRAP	Sage Products, Inc.	1978-10-17
K780167	CATH KIT, URINE SPECIMEN	C.R. Bard, Inc.	1978-02-21
K780057	URINE SAMPLE COLLECTION KIT	C.R. Bard, Inc.	1978-02-21
K780049	SPECIMEN COLLECTION DEVICE	Urol, Inc.	1978-01-26
K770387	UNICATCH	W.G. Whitney Corp.	1977-04-05
K770231	MID-STREAM COLLECTION SET	Chesire Laboratories	1977-03-30
K770112	SPECIMEN COLLECTOR	Portex, Inc.	1977-03-14
K761191	4 1/2 OZ. GRADUATED SPECIMEN CONTAINER	Superior Plastic Products Corp.	1977-02-28
K760496	CUP, DISPOSABLE SPECIMEN	Landmark Plastics	1976-11-12

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00879123009012	BFlex™	Verathon Medical (Canada) ULC	2026-05-29
H1084306551	Corning	Corning Incorporated	2026-01-26
H1083540141	Falcon A Corning Brand	Corning Incorporated	2026-01-23
H1083540171	Falcon A Corning Brand	Corning Incorporated	2026-01-23
H1083540201	Falcon A Corning Brand	Corning Incorporated	2026-01-23
H108117391	Corning	Corning Incorporated	2026-01-14
H108117041	Corning	Corning Incorporated	2025-10-28
H108117531	Corning	Corning Incorporated	2022-03-15
H108117541	Corning	Corning Incorporated	2022-03-15
H1084304901	Corning®	Corning Incorporated	2020-12-02
H1084304891	Corning®	Corning Incorporated	2020-12-02
H1084304881	Corning®	Corning Incorporated	2020-12-02
H1084304871	Corning®	Corning Incorporated	2020-12-02
H1084301791	Corning®	Corning Incorporated	2020-12-02
H1084304911	Corning®	Corning Incorporated	2020-12-02
H1084304921	Corning®	Corning Incorporated	2020-12-02
H1083540151	Falcon A Corning Brand	Corning Incorporated	2020-12-02
H1083520371	Falcon A Corning Brand	Corning Incorporated	2020-12-02
H1083540131	Falcon A Corning Brand	Corning Incorporated	2020-12-02
H1083520451	Falcon A Corning Brand	Corning Incorporated	2020-12-02
H1083520061	Falcon A Corning Brand	Corning Incorporated	2020-12-02
H1083520031	Falcon A Corning Brand	Corning Incorporated	2020-12-02
H1083520011	Falcon A Corning Brand	Corning Incorporated	2020-12-02
H10820281	Corning®	Corning Incorporated	2020-12-02
H108117501	Corning	Corning Incorporated	2020-12-02
H108117061	Corning	Corning Incorporated	2020-12-02
H108117051	Corning	Corning Incorporated	2020-12-02
H108117021	Corning	Corning Incorporated	2020-12-02
H108117011	Corning	Corning Incorporated	2020-12-02
H108112601	Corning	Corning Incorporated	2020-12-02

Product code FMH

Related 510(k) Records#

Related GUDID Devices#