Hematology Quality Control Mixture
FDA 510(k) K823930 · Fisher Scientific Co., LLC
510(k) numberK823930
Submission
- Device name
- Hematology Quality Control Mixture
- Applicant
- Fisher Scientific Co., LLC
Mchenry, IL, US - Received
- December 29, 1982
- Decision date
- February 1, 1983
- 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 |
|---|---|---|---|
| K880608 | Msi-PcGJP · Traditional | Medical Specialties, Inc. | 03/21/1988SE |
| 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 |
|---|---|---|
| K930415 | Microhematocrit RotorGKG · Traditional | 03/23/1993SE |
| 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 |
Questions and answers
When was Hematology Quality Control Mixture cleared by the FDA?
Hematology Quality Control Mixture (K823930) received a 510(k) decision of Substantially Equivalent on February 1, 1983, 34 days after the submission was received.
What is the product code of K823930?
The FDA product code is GJP – Control, Platelet, a Class II (moderate risk) device regulated under 21 CFR 864.8625.