510(k) K800916
- Device
- P1 Blood Group Substance
- Applicant
- TRAVENOL LABORATORIES, S.A.
- 510(k) number
- K800916
- Product code
- KSX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-05-08
- Date received
- 1980-04-22
- Regulation
- 864.9160
- Classification name
- Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2432235
- 3017237798
- 1034569
- 3014717638
- 2029372
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KSX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K802533 | GAMMA LEWIS BLOOD GROUP SUBSTANCE | Gamma Biologicals, Inc. | 1980-11-12 |
| K802534 | GAMMA PI BLOOD GROUP SUBSTANCE | Gamma Biologicals, Inc. | 1980-11-12 |
| K781862 | BLOOD GROUP SUBSTANCE A | North American Biologicals, Inc. | 1978-12-20 |
| K781895 | BLOOD GROUP SUBSTANCE B | North American Biologicals, Inc. | 1978-12-20 |
| K781896 | BLOOD GROUP SUBSTANCE A,B | North American Biologicals, Inc. | 1978-12-20 |
| K771487 | LEWIS BLOOD GROUP SUBSTANCE | Ortho Diagnostics, Inc. | 1977-11-08 |
| K771488 | P1 BLOOD GROUP SUBSTANCE | Ortho Diagnostics, Inc. | 1977-11-08 |