Em-V
FDA 510(k) K781397 · Biological Corp. of America
510(k) numberK781397
Submission
- Device name
- Em-V
- Applicant
- Biological Corp. of America
Mchenry, IL, US - Received
- August 11, 1978
- Decision date
- September 14, 1978
- 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 |
| K791791 | Ortho Antibody Enhancement SolutionKSG · Traditional | Ortho Diagnostics, Inc. | 10/11/1979SE |
| 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 |
More from Ortho Diagnostics, Inc.
Questions and answers
When was Em-V cleared by the FDA?
Em-V (K781397) received a 510(k) decision of Substantially Equivalent on September 14, 1978, 34 days after the submission was received.
What is the product code of K781397?
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.