Msi-Hct
FDA 510(k) K924926 · Medical Specialties, Inc.
510(k) numberK924926
Submission
- Device name
- Msi-Hct
- Applicant
- Medical Specialties, Inc.
South Plainfield, NJ, US - Received
- September 30, 1992
- Decision date
- January 7, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GLK – Control, Hematocrit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
Other 510(k)s with product code GLK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121467 | Eurotrol Hematocrit ControlGLK · Traditional | Eurotrol B.V. | 05/10/2013SE |
| K021924 | Medica Easyqc Hematocrit ControlGLK · Traditional | Bionostics, Inc. | 06/24/2002SE |
| K020618 | Aalto Scientific Mirco Hematocrit ControlGLK · Traditional | Aalto Scientific, Ltd. | 05/14/2002SE |
| K964452 | HematachekGLK · Traditional | Richmond Diagnostics, Inc. | 02/20/1997SE |
| K961807 | Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4GLK · Traditional | Ciba Corning Diagnostics Corp. | 07/26/1996SE |
| K893562 | A.Qc HCT Level 1 and 2GLK · Traditional | Johnson & Johnson Professionals, Inc. | 07/14/1989SE |
More from Johnson & Johnson Professionals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K946201 | Stand, InfusionFOX · Traditional | 04/18/1995SE |
| K931947 | CheckpointJPK · Traditional | 06/18/1993SE |
| K926095 | Refractrol-SpJJX · Traditional | 01/26/1993SE |
| K896566 | Modified Fox Extra Gram Negative and PositiveJWY · Traditional | 02/09/1990SE |
| K883851 | Msi-Cal 8KRZ · Traditional | 11/22/1988SE |
| K883850 | Msi-Cal 16KRZ · Traditional | 11/22/1988SE |
| K883703 | Msi-Cal 7KRZ · Traditional | 11/22/1988SE |
| K880608 | Msi-PcGJP · Traditional | 03/21/1988SE |
| K880270 | Msi-Diff PlusJPK · Traditional | 03/01/1988SE |
| K872140 | (Msi) Path-SaverIFP · Traditional | 06/15/1987SE |
Questions and answers
When was Msi-Hct cleared by the FDA?
Msi-Hct (K924926) received a 510(k) decision of Substantially Equivalent on January 7, 1993, 99 days after the submission was received.
What is the product code of K924926?
The FDA product code is GLK – Control, Hematocrit, a Class II (moderate risk) device regulated under 21 CFR 864.8625.