FDA Product Code
FDA Product Code KPA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Pathology
- 21 CFR Citation
- 864.3800
510(k) Clearances — 21 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K933996 | PROFIBLOT | Tecan U.S., Ltd. | 1994-01-28 | Traditional | PDF ↗ |
| K884258 | VERSABLOT | American Bionetics, Inc. | 1988-12-14 | Traditional | PDF ↗ |
| K881592 | WESCOR MODEL 7300 AEROSPRAY GRAM STAINER | Wescor, Inc. | 1988-05-13 | Traditional | PDF ↗ |
| K880745 | LX-100 SLIDE STAINER | Innovative Medical Systems, Inc. | 1988-04-27 | Traditional | PDF ↗ |
| K874887 | WESBLOT PROCESSOR | American Bionetics, Inc. | 1988-03-24 | Traditional | PDF ↗ |
| K874897 | SAKURA DRS-60 AUTOMATIC SLIDE STAINER | Sakura Finetek U.S.A., Inc. | 1988-01-05 | Traditional | PDF ↗ |
| K872916 | HISTOMATIC SLIDE STAINER, CODE-ON VERSION | Fisher Scientific Co., LLC | 1987-09-14 | Traditional | PDF ↗ |
| K853210 | MST-1050-II X-RAY UNIT | Radiological Engineering, Inc. | 1985-10-10 | Traditional | PDF ↗ |
| K850157 | CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS | Shaban Mfg. Co. | 1985-02-27 | Traditional | PDF ↗ |
| K850333 | PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS | Shaban Mfg. Co. | 1985-02-27 | Traditional | PDF ↗ |
| K842077 | MIDAS II AUTOMATIC STAINER | Innovative Medical Systems, Inc. | 1984-07-27 | Traditional | PDF ↗ |
| K833295 | WESCOR 7100 AEROSPRAY SLIDE STAINER | Wescor, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K832994 | MIDAS 6000 AUTOMATIC STAINER | Innovative Medical Systems, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K821830 | MI DAS 1000 AUTOMATIC SLIDE STAINER | Innovative Medical Systems, Inc. | 1982-07-22 | Traditional | PDF ↗ |
| K811697 | GUAMSTAINER | Tomtec | 1981-07-02 | Traditional | PDF ↗ |
| K781598 | TECHNICON AUTOSLIDE STAINING/PROCESSING | Technicon Instruments Corp. | 1978-10-17 | Traditional | PDF ↗ |
| K780637 | HEMATOLOGY SLIDE STAINER | A. J. P. Scientific, Inc. | 1978-05-19 | Traditional | PDF ↗ |
| K780017 | AUTO. SLIDE STAINER | Honeywell, Inc. | 1978-01-30 | Traditional | PDF ↗ |
| K771699 | CARA-STAIN MODEL 3000 | American Safety Equipment Corp. | 1977-09-13 | Traditional | PDF ↗ |
| K771559 | HEMA-TEK II SLIDE STAINER | Miles Laboratories, Inc. | 1977-08-25 | Traditional | PDF ↗ |
| K770076 | BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACK | Jack W. Kindberg | 1977-03-22 | Traditional | PDF ↗ |
Product code KPA · Class I · Pathology. Data: openFDA.