Platelet Controls Normal & Abnormal
FDA 510(k) K771588 · Dade, Baxter Travenol Diagnostics, Inc.
510(k) numberK771588
Submission
- Device name
- Platelet Controls Normal & Abnormal
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
Mchenry, IL, US - Received
- August 18, 1977
- Decision date
- August 25, 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 |
| 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 |
|---|---|---|
| K800296 | Whole Blood Gas Control, Levels 1,2,&3GGM · Traditional | 03/05/1980SE |
| K792606 | Whole Blood Platelet Control Normal,JPK · Traditional | 02/13/1980SE |
| K792723 | Blood Fluid FiltersJKA · Traditional | 01/21/1980SE |
| K792607 | T3 Uptake (T3U) ReagentsKHQ · Traditional | 01/16/1980SE |
| K792443 | TSH RadioimmunoassayJLW · Traditional | 12/27/1979SE |
| K792442 | Ferritin RadioimmunoassayDBF · Traditional | 12/18/1979SE |
| K791922 | Harleco Brand Clinicard Lipase Test SetCET · Traditional | 11/27/1979SE |
| K792183 | Dade High Density Lipoprotein CholesteroLBS · Traditional | 11/13/1979SE |
| K790776 | Dade Low Ionic Strength Soluition (Liss)KSG · Traditional | 05/23/1979SE |
| K790767 | Immu-Tek Automatic CentrifugeKSN · Traditional | 05/23/1979SE |
Questions and answers
When was Platelet Controls Normal & Abnormal cleared by the FDA?
Platelet Controls Normal & Abnormal (K771588) received a 510(k) decision of Substantially Equivalent on August 25, 1977, 7 days after the submission was received.
What is the product code of K771588?
The FDA product code is GJP – Control, Platelet, a Class II (moderate risk) device regulated under 21 CFR 864.8625.