Spuncrit
FDA 510(k) K925863 · bioMerieux, Inc.
510(k) numberK925863
Submission
- Device name
- Spuncrit
- Applicant
- bioMerieux, Inc.
Bethlehem, PA, US - Received
- November 19, 1992
- Decision date
- February 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961803 | Spuncrit (Model DRC-40)GKG · Traditional | Micro Diagnostics Corp. | 07/05/1996SE |
| K955795 | Multi-CentrifugeGKG · Traditional | Novonx, Inc. | 03/29/1996SE |
| K930415 | Microhematocrit RotorGKG · Traditional | Fisher Scientific Co., LLC | 03/23/1993SE |
| 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 |
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Questions and answers
When was Spuncrit cleared by the FDA?
Spuncrit (K925863) received a 510(k) decision of Substantially Equivalent on February 5, 1993, 78 days after the submission was received.
What is the product code of K925863?
The FDA product code is GKG – Centrifuge, Hematocrit, a Class II (moderate risk) device regulated under 21 CFR 864.6400.