FMH · Container, Specimen, Sterile
Pathology · 21 CFR 864.3250 · Class 1
Overview
| Product Code | FMH |
|---|---|
| Device Name | Container, Specimen, Sterile |
| Regulation | 21 CFR 864.3250 |
| Device Class | Class 1 |
| Review Panel | Pathology |
Identification
A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K900983 | TRI-TECH URINE SPECIMEN KIT | Tri-Tech, Inc. | Sep 17, 1990 | SESE |
| K823763 | VARIOUS-SPECIMEN COLLECTORS | Cordis Corp. | Jan 19, 1983 | SESE |
| K820180 | CALCULI FILTER CUP | Omnimedical | Feb 5, 1982 | SESE |
| K812933 | LANCER SPECIMEN CONTAINER | Sherwood Medical Co. | Nov 6, 1981 | SESE |
| K802340 | SPECIMEN SET | American Pharmaseal Div. Ahsc | Oct 10, 1980 | SESE |
| K802002 | URINE SPECIMEN CONTAINER #'S 1013-1016 | Pollak (Intl.), Ltd. | Sep 9, 1980 | SESE |
| K800947 | MIDSTREAM COLLECTION KIT | Sage Products, Inc. | May 30, 1980 | SESE |
| K800309 | SPECIMEN COLLECTION PAN | Sage Products, Inc. | Feb 26, 1980 | SESE |
| K800233 | ABCO MIDSTREAM URINE COLLECTION SET | Abco Dealers, Inc. | Feb 26, 1980 | SESE |
| K792710 | PARA-PAK CLEAN VIAL | Meridian Diagnostics, Inc. | Jan 28, 1980 | SESE |
| K792156 | LANCER SPECIMEN CONTAINER | Sherwood Medical Co. | Dec 10, 1979 | SESE |
| K792211 | SPECIMAN CUP & EMESIS BASIN | General Clinical Plastics Corp. | Nov 16, 1979 | SESE |
| K790915 | JUHN TYM-TAP | Xomed, Inc. | Jun 27, 1979 | SESE |
| K790291 | OPERATING ROOM SPECIMEN CONTAINER | Sage Products, Inc. | Apr 10, 1979 | SESE |
| K781557 | 24-HOUR URINE COLLECTION COOLING WRAP | Sage Products, Inc. | Oct 17, 1978 | SESE |
| K780167 | CATH KIT, URINE SPECIMEN | C.R. Bard, Inc. | Feb 21, 1978 | SESE |
| K780057 | URINE SAMPLE COLLECTION KIT | C.R. Bard, Inc. | Feb 21, 1978 | SESE |
| K780049 | SPECIMEN COLLECTION DEVICE | Urol, Inc. | Jan 26, 1978 | SESE |
| K770387 | UNICATCH | W.G. Whitney Corp. | Apr 5, 1977 | SESE |
| K770231 | MID-STREAM COLLECTION SET | Chesire Laboratories | Mar 30, 1977 | SESE |
Top Applicants
- Sage Products, Inc. — 4 clearances
- C.R. Bard, Inc. — 2 clearances
- Sherwood Medical Co. — 2 clearances
- Abco Dealers, Inc. — 1 clearance
- American Pharmaseal Div. Ahsc — 1 clearance
