Histomatic Slide Stainer, Code-On Version
FDA 510(k) K872916 · Fisher Scientific Co., LLC
510(k) numberK872916
Submission
- Device name
- Histomatic Slide Stainer, Code-On Version
- Applicant
- Fisher Scientific Co., LLC
Indiana, PA, US - Received
- July 24, 1987
- Decision date
- September 14, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KPA
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|---|---|---|---|
| K933996 | ProfiblotKPA · Traditional | Tecan U.S., Ltd. | 01/28/1994SE |
| K884258 | VersablotKPA · Traditional | American Bionetics, Inc. | 12/14/1988SE |
| K881592 | Wescor Model 7300 Aerospray Gram StainerKPA · Traditional | Wescor, Inc. | 05/13/1988SE |
| K880745 | LX-100 Slide StainerKPA · Traditional | Innovative Medical Systems, Inc. | 04/27/1988SE |
| K874887 | Wesblot ProcessorKPA · Traditional | American Bionetics, Inc. | 03/24/1988SE |
| K874897 | Sakura DRS-60 Automatic Slide StainerKPA · Traditional | Sakura Finetek U.S.A., Inc. | 01/05/1988SE |
| K853210 | MST-1050-II X-Ray UnitKPA · Traditional | Radiological Engineering, Inc. | 10/10/1985SE |
| K850333 | Pump Tube Sets for Hema-Tek I & II Slide StainersKPA · Traditional | Shaban Mfg. Co. | 02/27/1985SE |
| K850157 | Cannulas for Hema-Tek I & KK Slide StainersKPA · Traditional | Shaban Mfg. Co. | 02/27/1985SE |
| K842077 | Midas II Automatic StainerKPA · Traditional | Innovative Medical Systems, Inc. | 07/27/1984SE |
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| 510(k) | Device | Decision |
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| K930415 | Microhematocrit RotorGKG · Traditional | 03/23/1993SE |
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| K915441 | Marathon 13K/H Microhematocrit CentrifugeGKF · Traditional | 01/08/1992SE |
| K890534 | Modified Uriqual(Tm) Urinalysis Control Level 1JJW · Traditional | 03/08/1989SE |
| K881275 | Uriqual(Tm) Urinalysis Controls (Human) I & IIJJY · Traditional | 05/16/1988SE |
| K874054 | Fisher Diagnostics Hematall III Las ReagentGGK · Traditional | 10/20/1987SE |
| K871058 | Serachem Liquid Spinal Fluid Control (Human)JJY · Traditional | 04/06/1987SE |
| K863224 | Hematall-C Plus Hematology ControlsJPK · Traditional | 10/29/1986SE |
| K862318 | Fisher Diagnostics Hematall-C CalibratorJPK · Traditional | 07/10/1986SE |
| K861185 | Therachem-Plus, Tri-Level TDC (TM)JJY · Traditional | 05/23/1986SE |
Questions and answers
When was Histomatic Slide Stainer, Code-On Version cleared by the FDA?
Histomatic Slide Stainer, Code-On Version (K872916) received a 510(k) decision of Substantially Equivalent on September 14, 1987, 52 days after the submission was received.
What is the product code of K872916?
The FDA product code is KPA – Slide Stainer, Automated, a Class I (low risk) device regulated under 21 CFR 864.3800.