FMH — Container, Specimen, Sterile Class I
FDA Device Classification
Classification Details
- Product Code
- FMH
- Device Class
- Class I
- Regulation Number
- 864.3250
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Pathology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K900983 | tri-tech | TRI-TECH URINE SPECIMEN KIT | September 17, 1990 |
| K823763 | cordis | VARIOUS-SPECIMEN COLLECTORS | January 19, 1983 |
| K820180 | omnimedical | CALCULI FILTER CUP | February 5, 1982 |
| K812933 | sherwood medical | LANCER SPECIMEN CONTAINER | November 6, 1981 |
| K802340 | american pharmaseal div. ahsc | SPECIMEN SET | October 10, 1980 |
| K802002 | pollak (intl.) | URINE SPECIMEN CONTAINER #'S 1013-1016 | September 9, 1980 |
| K800947 | sage products | MIDSTREAM COLLECTION KIT | May 30, 1980 |
| K800309 | sage products | SPECIMEN COLLECTION PAN | February 26, 1980 |
| K800233 | abco dealers | ABCO MIDSTREAM URINE COLLECTION SET | February 26, 1980 |
| K792710 | meridian diagnostics | PARA-PAK CLEAN VIAL | January 28, 1980 |
| K792156 | sherwood medical | LANCER SPECIMEN CONTAINER | December 10, 1979 |
| K792211 | general clinical plastics | SPECIMAN CUP & EMESIS BASIN | November 16, 1979 |
| K790915 | xomed | JUHN TYM-TAP | June 27, 1979 |
| K790291 | sage products | OPERATING ROOM SPECIMEN CONTAINER | April 10, 1979 |
| K781557 | sage products | 24-HOUR URINE COLLECTION COOLING WRAP | October 17, 1978 |
| K780057 | c.r. bard | URINE SAMPLE COLLECTION KIT | February 21, 1978 |
| K780167 | c.r. bard | CATH KIT, URINE SPECIMEN | February 21, 1978 |
| K780049 | urol | SPECIMEN COLLECTION DEVICE | January 26, 1978 |
| K770387 | w.g. whitney | UNICATCH | April 5, 1977 |
| K770231 | chesire laboratories | MID-STREAM COLLECTION SET | March 30, 1977 |