Msi-Pc
FDA 510(k) K880608 · Medical Specialties, Inc.
510(k) numberK880608
Submission
- Device name
- Msi-Pc
- Applicant
- Medical Specialties, Inc.
South Plainfield, NJ, US - Received
- February 12, 1988
- Decision date
- March 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GJP – Control, Platelet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
Other 510(k)s with product code GJP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K823930 | Hematology Quality Control MixtureGJP · Traditional | Fisher Scientific Co., LLC | 02/01/1983SE |
| K771588 | Platelet Controls Normal & AbnormalGJP · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 08/25/1977SE |
| K770655 | Latelet Determibation Kit, Ul 800GJP · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/24/1977SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K946201 | Stand, InfusionFOX · Traditional | 04/18/1995SE |
| K931947 | CheckpointJPK · Traditional | 06/18/1993SE |
| K926095 | Refractrol-SpJJX · Traditional | 01/26/1993SE |
| K924926 | Msi-HctGLK · Traditional | 01/07/1993SE |
| 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 |
| K880270 | Msi-Diff PlusJPK · Traditional | 03/01/1988SE |
| K872140 | (Msi) Path-SaverIFP · Traditional | 06/15/1987SE |
Questions and answers
When was Msi-Pc cleared by the FDA?
Msi-Pc (K880608) received a 510(k) decision of Substantially Equivalent on March 21, 1988, 38 days after the submission was received.
What is the product code of K880608?
The FDA product code is GJP – Control, Platelet, a Class II (moderate risk) device regulated under 21 CFR 864.8625.