510(k) K802534
- Device
- GAMMA PI BLOOD GROUP SUBSTANCE
- Applicant
- GAMMA BIOLOGICALS, INC.
- 510(k) number
- K802534
- Product code
- KSX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-11-12
- Date received
- 1980-10-15
- 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 |
| K800916 | P1 BLOOD GROUP SUBSTANCE | Travenol Laboratories, S.A. | 1980-05-08 |
| 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 |
Legacy Summary#
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FDA Review#
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