Latelet Determibation Kit, Ul 800
FDA 510(k) K770655 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK770655
Submission
- Device name
- Latelet Determibation Kit, Ul 800
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- April 6, 1977
- Decision date
- June 24, 1977
- 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 |
| 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 |
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| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
Questions and answers
When was Latelet Determibation Kit, Ul 800 cleared by the FDA?
Latelet Determibation Kit, Ul 800 (K770655) received a 510(k) decision of Substantially Equivalent on June 24, 1977, 79 days after the submission was received.
What is the product code of K770655?
The FDA product code is GJP – Control, Platelet, a Class II (moderate risk) device regulated under 21 CFR 864.8625.