Blood Group Substance B
FDA 510(k) K781895 · North American Biologicals, Inc.
510(k) numberK781895
Submission
- Device name
- Blood Group Substance B
- Applicant
- North American Biologicals, Inc.
Mchenry, IL, US - Received
- November 6, 1978
- Decision date
- December 20, 1978
- 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 |
|---|---|---|---|
| K802534 | Gamma Pi Blood Group SubstanceKSX · Traditional | Gamma Biologicals, Inc. | 11/12/1980SE |
| 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 |
| 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 |
|---|---|---|
| K820301 | Plasma Pooler Heat SealerKSD · Traditional | 04/09/1982SE |
| K801219 | PlasmapoolerKSR · Traditional | 10/31/1980SE |
| K801425 | RH ControlKSF · Traditional | 07/14/1980SE |
| K781896 | Blood Group Substance A,BKSX · Traditional | 12/20/1978SE |
| K781862 | Blood Group Substance aKSX · Traditional | 12/20/1978SE |
Questions and answers
When was Blood Group Substance B cleared by the FDA?
Blood Group Substance B (K781895) received a 510(k) decision of Substantially Equivalent on December 20, 1978, 44 days after the submission was received.
What is the product code of K781895?
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.