meddevicedb.com FDA Device Reference

FDA Product Code

FDA Product Code FMH — Clearance Directory

Device Class
Class I
Assigned Panel
Pathology
21 CFR Citation
864.3250

510(k) Clearances — 23 records

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

Product code FMH · Class I · Pathology. Data: openFDA.