Slide Stainer, Automated
Regulation 864.3800
0510(k)s in 12 months (21 all time)
0recalls in 12 months (30 all time)
0recalls that name a 510(k)
Top companies in KPA
| Company | 510(k)s | Recalls |
|---|---|---|
| Ventana Medical Systems Inc | 0 | 11 |
| Innovative Medical Systems, Inc. | 4 | 0 |
| Beckman Coulter Inc | 0 | 3 |
| Dako North America Inc. | 0 | 3 |
| American Bionetics, Inc. | 2 | 0 |
| Dako Denmark A/S | 0 | 2 |
| Hardy Diagnostics | 0 | 2 |
| Leica Microsystems, Inc. | 0 | 2 |
| Roche Diagnostics Operations, Inc. | 0 | 2 |
| Shaban Mfg. Co. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 28, 1994 | K933996 | PROFIBLOT Tecan U.S., Ltd. | KPA |
| Dec 14, 1988 | K884258 | VERSABLOT American Bionetics, Inc. | KPA |
| May 13, 1988 | K881592 | WESCOR MODEL 7300 AEROSPRAY GRAM STAINER Wescor, Inc. | KPA |
| Apr 27, 1988 | K880745 | LX-100 SLIDE STAINER Innovative Medical Systems, Inc. | KPA |
| Mar 24, 1988 | K874887 | WESBLOT PROCESSOR American Bionetics, Inc. | KPA |
| Jan 5, 1988 | K874897 | SAKURA DRS-60 AUTOMATIC SLIDE STAINER Sakura Finetek U.S.A., Inc. | KPA |
| Sep 14, 1987 | K872916 | HISTOMATIC SLIDE STAINER, CODE-ON VERSION Fisher Scientific Co., LLC | KPA |
| Oct 10, 1985 | K853210 | MST-1050-II X-RAY UNIT Radiological Engineering, Inc. | KPA |
| Feb 27, 1985 | K850333 | PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS Shaban Mfg. Co. | KPA |
| Feb 27, 1985 | K850157 | CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS Shaban Mfg. Co. | KPA |
| Jul 27, 1984 | K842077 | MIDAS II AUTOMATIC STAINER Innovative Medical Systems, Inc. | KPA |
| Oct 31, 1983 | K833295 | WESCOR 7100 AEROSPRAY SLIDE STAINER Wescor, Inc. | KPA |
| Sep 29, 1983 | K832994 | MIDAS 6000 AUTOMATIC STAINER Innovative Medical Systems, Inc. | KPA |
| Jul 22, 1982 | K821830 | MI DAS 1000 AUTOMATIC SLIDE STAINER Innovative Medical Systems, Inc. | KPA |
| Jul 2, 1981 | K811697 | GUAMSTAINER Tomtec | KPA |
| Oct 17, 1978 | K781598 | TECHNICON AUTOSLIDE STAINING/PROCESSING Technicon Instruments Corp. | KPA |
| May 19, 1978 | K780637 | HEMATOLOGY SLIDE STAINER A. J. P. Scientific, Inc. | KPA |
| Jan 30, 1978 | K780017 | AUTO. SLIDE STAINER Honeywell, Inc. | KPA |
| Sep 13, 1977 | K771699 | CARA-STAIN MODEL 3000 American Safety Equipment Corp. | KPA |
| Aug 25, 1977 | K771559 | HEMA-TEK II SLIDE STAINER Miles Laboratories, Inc. | KPA |
| Mar 22, 1977 | K770076 | BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACK Jack W. Kindberg | KPA |
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