Container, Specimen, Sterile
The Sterile Specimen Container is a sealed, sterile receptacle used to collect and transport biological specimens such as urine, tissue, or other bodily fluids for laboratory analysis without contamination. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FMH, regulated under 21 CFR 864.3250 in the Pathology specialty.
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Basic Information
- Product Code
- FMH
- Device Class
- FDA class 1
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 23 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K900983 | TRI-TECH URINE SPECIMEN KIT | Sep 17, 1990 | Substantially Equivalent | Tri-Tech, Inc. |
| K823763 | VARIOUS-SPECIMEN COLLECTORS | Jan 19, 1983 | Substantially Equivalent | Cordis Corp. |
| K820180 | CALCULI FILTER CUP | Feb 05, 1982 | Substantially Equivalent | Omnimedical |
| K812933 | LANCER SPECIMEN CONTAINER | Nov 06, 1981 | Substantially Equivalent | Sherwood Medical Co. |
| K802340 | SPECIMEN SET | Oct 10, 1980 | Substantially Equivalent | American Pharmaseal Div. Ahsc |
| K802002 | URINE SPECIMEN CONTAINER #'S 1013-1016 | Sep 09, 1980 | Substantially Equivalent | Pollak (Intl.), Ltd. |
| K800947 | MIDSTREAM COLLECTION KIT | May 30, 1980 | Substantially Equivalent | Sage Products, Inc. |
| K800309 | SPECIMEN COLLECTION PAN | Feb 26, 1980 | Substantially Equivalent | Sage Products, Inc. |
| K800233 | ABCO MIDSTREAM URINE COLLECTION SET | Feb 26, 1980 | Substantially Equivalent | Abco Dealers, Inc. |
| K792710 | PARA-PAK CLEAN VIAL | Jan 28, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792156 | LANCER SPECIMEN CONTAINER | Dec 10, 1979 | Substantially Equivalent | Sherwood Medical Co. |
| K792211 | SPECIMAN CUP & EMESIS BASIN | Nov 16, 1979 | Substantially Equivalent | General Clinical Plastics Corp. |
| K790915 | JUHN TYM-TAP | Jun 27, 1979 | Substantially Equivalent | Xomed, Inc. |
| K790291 | OPERATING ROOM SPECIMEN CONTAINER | Apr 10, 1979 | Substantially Equivalent | Sage Products, Inc. |
| K781557 | 24-HOUR URINE COLLECTION COOLING WRAP | Oct 17, 1978 | Substantially Equivalent | Sage Products, Inc. |
| K780167 | CATH KIT, URINE SPECIMEN | Feb 21, 1978 | Substantially Equivalent | C.R. Bard, Inc. |
| K780057 | URINE SAMPLE COLLECTION KIT | Feb 21, 1978 | Substantially Equivalent | C.R. Bard, Inc. |
| K780049 | SPECIMEN COLLECTION DEVICE | Jan 26, 1978 | Substantially Equivalent | Urol, Inc. |
| K770387 | UNICATCH | Apr 05, 1977 | Substantially Equivalent | W.G. Whitney Corp. |
| K770231 | MID-STREAM COLLECTION SET | Mar 30, 1977 | Substantially Equivalent | Chesire Laboratories |
| K770112 | SPECIMEN COLLECTOR | Mar 14, 1977 | Substantially Equivalent | Portex, Inc. |
| K761191 | 4 1/2 OZ. GRADUATED SPECIMEN CONTAINER | Feb 28, 1977 | Substantially Equivalent | Superior Plastic Products Corp. |
| K760496 | CUP, DISPOSABLE SPECIMEN | Nov 12, 1976 | Substantially Equivalent | Landmark Plastics |
FEI Numbers
This FDA classification entry is associated with 294 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 294 registration numbers. Click on an entry to view related FDA registrations.