meddevicedb.com FDA Device Reference

Review Panel

Pathology FDA 510(k) Clearances & Devices

Cleared Devices
343
Product Codes (page)
38
Latest Decision
1983-06-17

Clearances · page 3 of 4

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K831580 PARAFFIN INFILTRATION MEDIUM Surgipath Medical Industries, Inc. KEO Class I 1983-06-17
K831058 SAF FIXATIVE American Micro Scan LDW Class I 1983-06-08
K831065 SECTIONING AID KIT Technicon Instruments Corp. KEW Class I 1983-06-08
K831061 PVA FIXATIVE/FORMALIN American Micro Scan LDZ Class I 1983-06-08
K831334 TISSUE CASSETTES FOR PROCESSING-EM BED Surgipath Medical Industries, Inc. IDZ Class I 1983-05-25
K831333 EMBEDDING RINGS Surgipath Medical Industries, Inc. KER Class I 1983-05-25
K831335 DISPOSABLE BASE MOLD Surgipath Medical Industries, Inc. KER Class I 1983-05-16
K831308 DISPOSABLE MICROTOME BLADE Surgipath Medical Industries, Inc. IDL Class I 1983-05-16
K831200 IMMUNOHEMATOLOGICAL SALINE #97139 Emd Chemicals, Inc. JCE Class I 1983-05-09
K830515 SCOTTS TAP WATER SUBSTITUTE CONCENTRATE Surgipath Medical Industries, Inc. KEQ Class I 1983-03-31
K830627 CLARIFIER-RICHARD-ALLAN Richard-Allan Medical Ind., Inc. KEM Class I 1983-03-24
K830659 CLEARIUM, MOUNTING MEDIUM Surgipath Medical Industries, Inc. KEP Class I 1983-03-17
K830583 NEUTRAL BUFFERED FORMALIN 10% Surgipath Medical Industries, Inc. IFP Class I 1983-03-17
K830582 MILLONIG'S MODIFIED PHOSPHATE BUFFERED Surgipath Medical Industries, Inc. IFP Class I 1983-03-17
K830514 MILLONIGS MODIFIED PHOSPHATE BUFFERED Surgipath Medical Industries, Inc. IFP Class I 1983-03-08
K823773 PROVIAL II #006-010-0201 Dynatech Corp. KDT Class I 1983-01-21
K823763 VARIOUS-SPECIMEN COLLECTORS Cordis Corp. FMH Class I 1983-01-19
K823040 PATHOLOGY INSTRUMENTATION & ACCESSORIES Iris Remote Imaging Systems IBJ Class I 1983-01-14
K823747 24 CELL WELLS TISSUE CULTURE Corning Medical & Scientific KJG Class I 1983-01-05
K822784 HEMO-DE Pmp Industries KEM Class I 1982-11-05
K822870 STOOL-COLLECTION/PRESERVATION KIT American Scientific Products KDT Class I 1982-11-01
K822326 BLENDED DETERGENT-78N 1912-1 Interscience, Inc. PPM Class I 1982-10-18
K822207 2XC MICROSCOPE Amarel Precision Instruments, Inc. IBJ Class I 1982-08-05
K822127 VOLU-SOL ZENKERS FIXATIVE Volu Sol Medical Industries IFH Class I 1982-08-05
K822129 VOLU-SOL BOVINS FIXATIVE Volu Sol Medical Industries IGN Class I 1982-08-05
K822126 VOLU-SOL CARNOY FLUID Volu Sol Medical Industries IGM Class I 1982-08-05
K822036 VOLU-SOL DECALCIFER Volu Sol Medical Industries KDX Class I 1982-08-03
K822037 VOLU-SOL TAP WATER SUBSTITUTE Volu Sol Medical Industries PPM Class I 1982-08-03
K821830 MI DAS 1000 AUTOMATIC SLIDE STAINER Innovative Medical Systems, Inc. KPA Class I 1982-07-22
K821621 PREGNOPOST M.M. Wolfred, Ph.D. KDT Class I 1982-07-21
K821865 A O MICROSCOPE VIDEO SYSTEM Warner-Lambert Co. IBJ Class I 1982-07-14
K820336 DAKO PAP KIT K509 Dako Corp. LIJ Class I 1982-07-13
K821831 A O HISTOSTAT EMBEDDING CTR #8030,32,34 Warner-Lambert Co. IDS Class I 1982-07-13
K821443 FORMICAL Lerner Laboratories, Inc. KDX Class I 1982-06-02
K821019 PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU Microbiological Research Corp. LEB Class I 1982-04-26
K820100 FROSTED GLASS SLIDES Stan-Pak Ent. KEW Class I 1982-03-04
K820246 PREFILLED SPECIMEN CONTAINER Sage Products, Inc. KDT Class I 1982-02-18
K820180 CALCULI FILTER CUP Omnimedical FMH Class I 1982-02-05
K813430 TISSUE PROCESSING CASSETTES & ACCESS American Optical Corp. IDL Class I 1981-12-29
K812940 10% NEUTRAL BUFFERED FORMALIN CONCENT Surgipath IFP Class I 1981-12-10
K813242 QUANTIMETRIC 2 TEST KIT Kallestad Laboratories, Inc. KEW Class I 1981-12-02
K812817 NEUTRAL DUFFERED FORMA-SCENT Meridian Diagnostics, Inc. IFP Class I 1981-11-10
K812933 LANCER SPECIMEN CONTAINER Sherwood Medical Co. FMH Class I 1981-11-06
K812846 CLEAR-RITE II Richard-Allan Medical Ind., Inc. KEM Class I 1981-10-29
K812847 XYLENE Richard-Allan Medical Ind., Inc. KEM Class I 1981-10-29
K812558 TISSUE-TEK III ACCU-CUT ROTARY MICROTOME Miles Laboratories, Inc. IDO Class I 1981-09-29
K812497 IMMULIK STAIN PLATE Immulok, Inc. IEG Class I 1981-09-23
K812158 LKB-BROMMA 2188 ULTROTOME NOVA Lkb Instruments, Inc. IDM Class I 1981-09-16
K812193 KOH MOUNTING FLUID American Scientific Products LEB Class I 1981-08-31
K812191 VASPAR SEALENT American Scientific Products KEO Class I 1981-08-31
K811791 PHOSPHATE BUFFERED SALINE (1X) Dutchland Laboratories, Inc. JCC Class I 1981-08-25
K812157 LKB-BROMMA 2218 HISTORANGE MICROTOME Lkb Instruments, Inc. IDO Class I 1981-08-18
K811800 BLUING REAGENT Richard-Allan Medical Ind., Inc. PPM Class I 1981-08-12
K811799 CLEAR-MOUNT Richard-Allan Medical Ind., Inc. LEB Class I 1981-07-31
K811793 FIX-RIGHT 90ML & 180 ML PREFILLED CONT Richard-Allan Medical Ind., Inc. KDT Class I 1981-07-31
K811801 CAL-RITE Richard-Allan Medical Ind., Inc. KDX Class I 1981-07-28
K811794 37% FORMALDEHYDE Richard-Allan Medical Ind., Inc. IGG Class I 1981-07-28
K811798 CLEAR-RITE Richard-Allan Medical Ind., Inc. KEM Class I 1981-07-28
K811796 FORMAL ALCOHOL Richard-Allan Medical Ind., Inc. PPM Class I 1981-07-28
K811795 10% NEUTRAL BUFFERED FORMALDEHYDE Richard-Allan Medical Ind., Inc. IFP Class I 1981-07-28
K811697 GUAMSTAINER Tomtec KPA Class I 1981-07-02
K811251 CITRATE BUFFER Bioscientific JCC Class I 1981-05-21
K810836 DECALCIFIER II Surgipath KDX Class I 1981-04-23
K810848 CYTOBUCKET MODEL 1024 Cytochem, Inc. IFB Class I 1981-04-23
K802818 PULLEN POCKET SCOPE P.A. Research Corp. IBJ Class I 1981-04-17
K810568 PARAFFIN EMBEDDING MEDIUM Surgipath Medical Industries, Inc. KEO Class I 1981-03-17
K810323 ACRYTOL, MOUNTING MEDIUM Surgipath KEP Class I 1981-03-06
K803241 HISTOLOGICAL EMBEDDING MEDIA Miles Laboratories, Inc. KEO Class I 1981-01-28
K803050 SPRAY, SYNTHETIC SMEAR Laboratory Products, Inc. IFI Class I 1980-12-30
K803054 SAF FIXATIVE Remel Co. IGB Class I 1980-12-22
K802493 SPUTASOL Oxoid U.S.A., Inc. IBG Class I 1980-11-12
K802506 PLEASCENT OR FORMA-SCENT Meridian Diagnostics, Inc. IGG Class I 1980-11-12
K802340 SPECIMEN SET American Pharmaseal Div. Ahsc FMH Class I 1980-10-10
K802002 URINE SPECIMEN CONTAINER #'S 1013-1016 Pollak (Intl.), Ltd. FMH Class I 1980-09-09
K801427 TISSUE-TEK III MINI-RAPID PROCESSOR Miles Laboratories, Inc. IEO Class I 1980-07-28
K801506 CERTIFIED BLOOD BANK SALINE Nobel Scientific Industries, Inc. JCE Class I 1980-07-28
K801426 TISSUE-TEK III MICROJECT DISP. BLADE SYS Miles Laboratories, Inc. IDL Class I 1980-07-28
K801513 TISSUE PROCESSING SYSTEM Innovative Medical Systems, Inc. IEO Class I 1980-07-28
K800946 URINARY CATHETER SAMPLING KIT Sage Products, Inc. KDT Class I 1980-06-20
K800947 MIDSTREAM COLLECTION KIT Sage Products, Inc. FMH Class I 1980-05-30
K800847 ENTELLAN Mcb Manufacturing Chemists, Inc. KEP Class I 1980-05-08
K800233 ABCO MIDSTREAM URINE COLLECTION SET Abco Dealers, Inc. FMH Class I 1980-02-26
K800309 SPECIMEN COLLECTION PAN Sage Products, Inc. FMH Class I 1980-02-26
K800232 ABCO ULTRA SLIDE MICROSCOPE SLIDE Abco Dealers, Inc. KEW Class I 1980-02-21
K792710 PARA-PAK CLEAN VIAL Meridian Diagnostics, Inc. FMH Class I 1980-01-28
K792654 CULTURETTE BRAND-PVA/FORMALIN KIT Marion Laboratories, Inc. IFQ Class I 1980-01-24
K792703 LACTO-PHENOL ANALINE BLUE FLUID Meridian Diagnostics, Inc. KEQ Class I 1980-01-24
K792714 PARA-PAK PVA Meridian Diagnostics, Inc. IFQ Class I 1980-01-24
K792709 KOH MOUNTING FLUID W/GLYCEROL Meridian Diagnostics, Inc. KEQ Class I 1980-01-24
K792702 VASPAR SEALANT Meridian Diagnostics, Inc. KEQ Class I 1980-01-24
K792707 PARA-PAK SAF Meridian Diagnostics, Inc. IGG Class I 1980-01-21
K792574 MOPSO BUFFER Electrophoresis Corp. of America JCC Class I 1980-01-21
K792705 PARA-PAK FORMALIN Meridian Diagnostics, Inc. IGG Class I 1980-01-21
K792633 STERILIZATION PROCESS/OUTERWRAP Procter & Gamble Mfg. Co. KET Class I 1980-01-11
K792156 LANCER SPECIMEN CONTAINER Sherwood Medical Co. FMH Class I 1979-12-10
K792032 LEIF CENTRIFUGAL CYTOLOGY BUCKET Robert C. Leif, Ph.D. IFB Class I 1979-11-30
K792101 COUITER/CMS ISOTONIC BLOOD BANK SALINE Coulter Electronics, Inc. JCE Class I 1979-11-20
K792095 HISTO-CENTER II Thermolyne Corp. IDW Class I 1979-11-20
K792211 SPECIMAN CUP & EMESIS BASIN General Clinical Plastics Corp. FMH Class I 1979-11-16
K790915 JUHN TYM-TAP Xomed, Inc. FMH Class I 1979-06-27

343 clearances in the Pathology panel. Data: openFDA.