510(k) K930422
- Device
- SYNELISA PARIETAL CELL ANTIBODIES
- Applicant
- ELIAS USA, INC.
- 510(k) number
- K930422
- Product code
- DBJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-08-03
- Date received
- 1993-01-26
- Regulation
- 866.5110
- Classification name
- Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- 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
FDA Registration Numbers#
- 2242436
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DBJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K790759 | IIF-APCA TEST KIT | Medica Corp. | 1979-07-30 |
Legacy Summary#
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FDA Review#
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