Product code FMH— Pathology

FDA has cleared 23 devices under product code FMH between 1976 and 1990, filed by 18 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19901 clearance
• 19831 clearance
• 19821 clearance
• 19811 clearance
• 19806 clearances
• 19794 clearances
• 19784 clearances
• 19774 clearances
• 19761 clearance

• Sage Products, Inc.4 clearances
• Sherwood Medical Co.2 clearances
• C.R. Bard, Inc.2 clearances
• Xomed, Inc.1 clearance
• W.G. Whitney Corp.1 clearance
• Urol, Inc.1 clearance
• Tri-Tech, Inc.1 clearance
• Superior Plastic Products Corp.1 clearance
• Portex, Inc.1 clearance
• Pollak (Intl.), Ltd.1 clearance

• K900983 — TRI-TECH URINE SPECIMEN KITTri-Tech, Inc.·1990-09-17
• K823763 — VARIOUS-SPECIMEN COLLECTORSCordis Corp.·1983-01-19
• K820180 — CALCULI FILTER CUPOmnimedical·1982-02-05
• K812933 — LANCER SPECIMEN CONTAINERSherwood Medical Co.·1981-11-06
• K802340 — SPECIMEN SETAmerican Pharmaseal Div. Ahsc·1980-10-10
• K802002 — URINE SPECIMEN CONTAINER #'S 1013-1016Pollak (Intl.), Ltd.·1980-09-09
• K800947 — MIDSTREAM COLLECTION KITSage Products, Inc.·1980-05-30
• K800233 — ABCO MIDSTREAM URINE COLLECTION SETAbco Dealers, Inc.·1980-02-26
• K800309 — SPECIMEN COLLECTION PANSage Products, Inc.·1980-02-26
• K792710 — PARA-PAK CLEAN VIALMeridian Diagnostics, Inc.·1980-01-28
• K792156 — LANCER SPECIMEN CONTAINERSherwood Medical Co.·1979-12-10
• K792211 — SPECIMAN CUP & EMESIS BASINGeneral Clinical Plastics Corp.·1979-11-16
• K790915 — JUHN TYM-TAPXomed, Inc.·1979-06-27
• K790291 — OPERATING ROOM SPECIMEN CONTAINERSage Products, Inc.·1979-04-10
• K781557 — 24-HOUR URINE COLLECTION COOLING WRAPSage Products, Inc.·1978-10-17
• K780057 — URINE SAMPLE COLLECTION KITC.R. Bard, Inc.·1978-02-21
• K780167 — CATH KIT, URINE SPECIMENC.R. Bard, Inc.·1978-02-21
• K780049 — SPECIMEN COLLECTION DEVICEUrol, Inc.·1978-01-26
• K770387 — UNICATCHW.G. Whitney Corp.·1977-04-05
• K770231 — MID-STREAM COLLECTION SETChesire Laboratories·1977-03-30
• K770112 — SPECIMEN COLLECTORPortex, Inc.·1977-03-14
• K761191 — 4 1/2 OZ. GRADUATED SPECIMEN CONTAINERSuperior Plastic Products Corp.·1977-02-28
• K760496 — CUP, DISPOSABLE SPECIMENLandmark Plastics·1976-11-12