Lewis Blood Group Substance
FDA 510(k) K771487 · Ortho Diagnostics, Inc.
510(k) numberK771487
Submission
- Device name
- Lewis Blood Group Substance
- Applicant
- Ortho Diagnostics, Inc.
Mchenry, IL, US - Received
- August 5, 1977
- Decision date
- November 8, 1977
- 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 |
| 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 |
More from Ortho Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802404 | Ortho Bovine Albumin Solution 30% ProteDCF · Traditional | 10/23/1980SE |
| K801507 | Antigen Control CellsGOL · Traditional | 08/20/1980SE |
| K800357 | Bi-Level Assayed Card. Drug Cont., I,IiLAS · Traditional | 04/16/1980SE |
| K800310 | Ortho Antisera ControlKSF · Traditional | 03/05/1980SE |
| K791791 | Ortho Antibody Enhancement SolutionKSG · Traditional | 10/11/1979SE |
| K791301 | Ortho TSH Ria KitJLW · Traditional | 09/24/1979SE |
| K790813 | Multecon Blood Gas ControlJJS · Traditional | 06/28/1979SE |
| K782166 | Slide Test for Pregnancy, Gravindex 90JHJ · Traditional | 04/04/1979SE |
| K782063 | Pregnancy, Sensidex Tube TestJHJ · Traditional | 04/04/1979SE |
| K781638 | Rubindex*Direct SystemGOK · Traditional | 12/20/1978SE |
Questions and answers
When was Lewis Blood Group Substance cleared by the FDA?
Lewis Blood Group Substance (K771487) received a 510(k) decision of Substantially Equivalent on November 8, 1977, 95 days after the submission was received.
What is the product code of K771487?
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.