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Review Panel

Pathology FDA 510(k) Clearances & Devices

Cleared Devices
343
Product Codes (page)
22
Latest Decision
1979-05-15

Clearances · page 4 of 4

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K790815 CULTURETTE BRAND PVA Marion Laboratories, Inc. IGM Class I 1979-05-15
K790291 OPERATING ROOM SPECIMEN CONTAINER Sage Products, Inc. FMH Class I 1979-04-10
K781868 DROPPER, CEPTI-SEAL LAVTOPHENOL Marion Laboratories, Inc. KEQ Class I 1978-11-22
K781869 DROPPER, CEPTI-SEAL KOH SOLUTION Marion Laboratories, Inc. KEQ Class I 1978-11-22
K781598 TECHNICON AUTOSLIDE STAINING/PROCESSING Technicon Instruments Corp. KPA Class I 1978-10-17
K781557 24-HOUR URINE COLLECTION COOLING WRAP Sage Products, Inc. FMH Class I 1978-10-17
K781388 F.A. MOUNTING MEDIUM Flow Laboratories, Inc. KEQ Class I 1978-08-21
K780637 HEMATOLOGY SLIDE STAINER A. J. P. Scientific, Inc. KPA Class I 1978-05-19
K780261 COVERSLIPPER Shandon, Inc. KIM Class I 1978-04-18
K780057 URINE SAMPLE COLLECTION KIT C.R. Bard, Inc. FMH Class I 1978-02-21
K780167 CATH KIT, URINE SPECIMEN C.R. Bard, Inc. FMH Class I 1978-02-21
K780017 AUTO. SLIDE STAINER Honeywell, Inc. KPA Class I 1978-01-30
K780049 SPECIMEN COLLECTION DEVICE Urol, Inc. FMH Class I 1978-01-26
K761138 FA TISSUE FIXATIVE & WASH SET Zeus Scientific, Inc. LDZ Class I 1978-01-06
K772149 LANCER BIOPSY HOLDER Sherwood Medical Industries KER Class I 1977-11-22
K771955 TRYPSIN 1% Flow Laboratories, Inc. IBG Class I 1977-11-22
K771925 KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP Harleco KES Class I 1977-11-02
K771714 SLIDE STAINERS GLS 360 & 360-1 Honeywell, Inc. KEY Class I 1977-10-05
K771699 CARA-STAIN MODEL 3000 American Safety Equipment Corp. KPA Class I 1977-09-13
K771559 HEMA-TEK II SLIDE STAINER Miles Laboratories, Inc. KPA Class I 1977-08-25
K771201 FORMALIN BUFFER CONCENTRATE Central Labs. Assoc. MD Pathologists IGG Class I 1977-08-22
K771308 TISSUE-TEK III V.I.P. Miles Laboratories, Inc. IEO Class I 1977-08-22
K770652 FLUORESCENCE ILLUMINATOR ACCESSORY Bausch & Lomb, Inc. IBK Class I 1977-07-06
K770592 CYTOLOGY FIXATIVE Surgipath Medical Industries, Inc. LEA Class I 1977-05-20
K770508 SMAC SYSTEM Mid Tech, Inc. JCC Class I 1977-05-09
K770387 UNICATCH W.G. Whitney Corp. FMH Class I 1977-04-05
K770231 MID-STREAM COLLECTION SET Chesire Laboratories FMH Class I 1977-03-30
K770076 BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACK Jack W. Kindberg KPA Class I 1977-03-22
K770112 SPECIMEN COLLECTOR Portex, Inc. FMH Class I 1977-03-14
K761062 HISTO-TEK W/ AUTOMATIC COVERSLIPPER Miles Laboratories, Inc. IEO Class I 1977-03-07
K761191 4 1/2 OZ. GRADUATED SPECIMEN CONTAINER Superior Plastic Products Corp. FMH Class I 1977-02-28
K770071 PINLOCK CONTAINER Perkins Mfg. Co. KDT Class I 1977-02-24
K761183 LYSING AGENT AF Central Labs. Assoc. MD Pathologists JCE Class I 1977-01-17
K761170 BARBITAL SALINE BUFFER Bio/Data Corp. JCE Class I 1977-01-10
K761174 PHYSIOLOGIC SALINE (0.85%) Bio/Data Corp. JCE Class I 1977-01-10
K761000 PAP-TRAY I (CATALOG #C600-1) Lerner Laboratories, Inc. LEA Class I 1976-12-06
K761001 PAP-TRAY II (CATALOG #C600-2) Lerner Laboratories, Inc. LEA Class I 1976-12-06
K760838 LACTO-PHENOL COTTON BLUE MOUNTING FL. I M, Inc. LEB Class I 1976-11-16
K760496 CUP, DISPOSABLE SPECIMEN Landmark Plastics FMH Class I 1976-11-12
K760623 LANCER PARAPLAST HISTO PROCESS CASSETTE Sherwood Medical Industries IDZ Class I 1976-09-27
K760602 SORVALL EMBEDDING MEDIUM E.I. Dupont DE Nemours & Co., Inc. KEO Class I 1976-09-21
K760278 SLIDE, LAB-TEK COVERED MICRO Miles Laboratories, Inc. KEW Class I 1976-08-30
K760032 TEST, MONO., DIFFERENTIAL SLIDE Gamma Biologicals, Inc. KIN Class I 1976-08-03

343 clearances in the Pathology panel. Data: openFDA.