510(k) K933123
- Device
- SYNELISA TG ANTIBODIES/TPO ANTIBODIES
- Applicant
- ELIAS U.S.A., INC.
- 510(k) number
- K933123
- Product code
- JZS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-08-23
- Date received
- 1993-06-28
- Regulation
- 866.4500
- Classification name
- Electrophoresis Instrumentation
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GOTTFRIED KELLERMANN
- Address
- 373 280th St. Osceola WI US 54020 54020
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JZS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K812194 | IMMUNODIFFUSION BAND INTENSIFYING FLUID | American Scientific Products | 1981-08-31 |
| K770566 | IMMUNOELECTROPHORESIS PROFILE KIT | Kallestad Laboratories, Inc. | 1977-04-27 |
| K770718 | STAIN, R-250, COOMASSIE BRILLIANT BLUE | Kallestad Laboratories, Inc. | 1977-04-26 |
| K770719 | IMMUNOELECTROFILM KIH | Kallestad Laboratories, Inc. | 1977-04-26 |
| K770150 | ELECTRO IMMUNO ASSAY KIT | Millipore Corp. | 1977-02-01 |
Legacy Summary#
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FDA Review#
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