Microhematocrit Rotor
FDA 510(k) K930415 · Fisher Scientific Co., LLC
510(k) numberK930415
Submission
- Device name
- Microhematocrit Rotor
- Applicant
- Fisher Scientific Co., LLC
Pittsburgh, PA, US - Received
- January 26, 1993
- Decision date
- March 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GKG – Centrifuge, Hematocrit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6400
- Specialty
- Hematology
Other 510(k)s with product code GKG
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|---|---|---|---|
| K961803 | Spuncrit (Model DRC-40)GKG · Traditional | Micro Diagnostics Corp. | 07/05/1996SE |
| K955795 | Multi-CentrifugeGKG · Traditional | Novonx, Inc. | 03/29/1996SE |
| K925863 | SpuncritGKG · Traditional | bioMerieux, Inc. | 02/05/1993SE |
| K920207 | Hermle Z230HGKG · Traditional | Labnet Intl., Inc. | 06/09/1992SE |
| K920759 | Critspin Micro-HematocritGKG · Traditional | Stat-Spin Technologies | 04/29/1992SE |
| K913128 | Hematastat C-70BGKG · Traditional | Separation Technology, Inc. | 09/23/1991SE |
| K890849 | Hematastat H-70GKG · Traditional | Separation Technology, Inc. | 03/21/1989SE |
| K822445 | HCT CentrifugeGKG · Traditional | Boehringer Mannheim Corp. | 09/14/1982SE |
| K821803 | QBC Centrifugal Hematology SystemGKG · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/14/1982SE |
| K813033 | Clay Adams QBC Centrifugal HemotologyGKG · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/09/1982SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K915825 | Marathon 6K General-Purpose CentrifugeGKF · Traditional | 03/11/1992SE |
| 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 |
| K872916 | Histomatic Slide Stainer, Code-On VersionKPA · Traditional | 09/14/1987SE |
| 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 Microhematocrit Rotor cleared by the FDA?
Microhematocrit Rotor (K930415) received a 510(k) decision of Substantially Equivalent on March 23, 1993, 56 days after the submission was received.
What is the product code of K930415?
The FDA product code is GKG – Centrifuge, Hematocrit, a Class II (moderate risk) device regulated under 21 CFR 864.6400.