Ortho Antibody Enhancement Solution
FDA 510(k) K791791 · Ortho Diagnostics, Inc.
510(k) numberK791791
Submission
- Device name
- Ortho Antibody Enhancement Solution
- Applicant
- Ortho Diagnostics, Inc.
Mchenry, IL, US - Received
- September 11, 1979
- Decision date
- October 11, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSG – Media, Potentiating For In Vitro Diagnostic Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9600
- Specialty
- Hematology
Other 510(k)s with product code KSG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K812565 | Elution SolutionKSG · Traditional | Biological Corp. of America | 10/23/1981SE |
| K812222 | Em-XKSG · Traditional | Biological Corp. of America | 09/23/1981SE |
| K800943 | Pentex Bovine Albumin 30% SolutionKSG · Traditional | Miles Laboratories, Inc. | 05/08/1980SE |
| K800189 | Bovine Albumin 22% & 30% SolutionsKSG · Traditional | Gotham Biologics, Inc. | 02/13/1980SE |
| K791113 | Low Ionic Strength Solution (Liss)KSG · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 06/28/1979SE |
| K790973 | Lo-IonKSG · Traditional | Gamma Biologicals, Inc. | 06/15/1979SE |
| K790776 | Dade Low Ionic Strength Soluition (Liss)KSG · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 05/23/1979SE |
| K790498 | Liss ReagentKSG · Traditional | Fisher Scientific Co., LLC | 04/03/1979SE |
| K781435 | Ortho Low Ionic SolutionKSG · Traditional | Ortho Diagnostics, Inc. | 09/14/1978SE |
| K781397 | Em-VKSG · Traditional | Biological Corp. of America | 09/14/1978SE |
More from Biological Corp. of America
| 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 |
| 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 |
| K781860 | Assay, Chromogenic Antithrombin IIIJBQ · Traditional | 12/04/1978SE |
Questions and answers
When was Ortho Antibody Enhancement Solution cleared by the FDA?
Ortho Antibody Enhancement Solution (K791791) received a 510(k) decision of Substantially Equivalent on October 11, 1979, 30 days after the submission was received.
What is the product code of K791791?
The FDA product code is KSG – Media, Potentiating For In Vitro Diagnostic Use, a Class II (moderate risk) device regulated under 21 CFR 864.9600.