Gamma Pi Blood Group Substance
FDA 510(k) K802534 · Gamma Biologicals, Inc.
510(k) numberK802534
Submission
- Device name
- Gamma Pi Blood Group Substance
- Applicant
- Gamma Biologicals, Inc.
Mchenry, IL, US - Received
- October 15, 1980
- Decision date
- November 12, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSX – Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9160
- Specialty
- Hematology
Other 510(k)s with product code KSX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K802533 | Gamma Lewis Blood Group SubstanceKSX · Traditional | Gamma Biologicals, Inc. | 11/12/1980SE |
| K800916 | P1 Blood Group SubstanceKSX · Traditional | Travenol Laboratories, S.A. | 05/08/1980SE |
| K781896 | Blood Group Substance A,BKSX · Traditional | North American Biologicals, Inc. | 12/20/1978SE |
| K781895 | Blood Group Substance BKSX · Traditional | North American Biologicals, Inc. | 12/20/1978SE |
| K781862 | Blood Group Substance aKSX · Traditional | North American Biologicals, Inc. | 12/20/1978SE |
| K771488 | P1 Blood Group SubstanceKSX · Traditional | Ortho Diagnostics, Inc. | 11/08/1977SE |
| K771487 | Lewis Blood Group SubstanceKSX · Traditional | Ortho Diagnostics, Inc. | 11/08/1977SE |
More from Ortho Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K864207 | Disposable Test Cards/Gamma Slide Test Infect MonoKTN · Traditional | 12/03/1986SE |
| K861016 | Gamma Slide Test for Infectious MononucleosisKTN · Traditional | 04/18/1986SE |
| K832473 | Gamma Slide Test for PregnancyJHJ · Traditional | 08/16/1983SE |
| K820647 | Gamma Fetal Bleed Screening TestLIM · Traditional | 05/12/1982SE |
| K820072 | Fe-Cult PlusKHE · Traditional | 03/04/1982SE |
| K813342 | Gamma Chloroquine Diphosphate SolutionKSK · Traditional | 03/04/1982SE |
| K811752 | Fe-Cult PlusKHE · Traditional | 11/02/1981SE |
| K802533 | Gamma Lewis Blood Group SubstanceKSX · Traditional | 11/12/1980SE |
| K800658 | Rst-Series ControlKSF · Traditional | 04/16/1980SE |
| K792583 | Gamma Arachis Hypogea LectinKSI · Traditional | 01/16/1980SE |
Questions and answers
When was Gamma Pi Blood Group Substance cleared by the FDA?
Gamma Pi Blood Group Substance (K802534) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 28 days after the submission was received.
What is the product code of K802534?
The FDA product code is KSX – Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use, a Class II (moderate risk) device regulated under 21 CFR 864.9160.