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.