510(k) K790759
- Device
- IIF-APCA TEST KIT
- Applicant
- MEDICA CORP.
- 510(k) number
- K790759
- Product code
- DBJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-07-30
- Date received
- 1979-04-17
- Regulation
- 866.5110
- Classification name
- Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- 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#
- 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 |
|---|---|---|---|
| K930422 | SYNELISA PARIETAL CELL ANTIBODIES | Elias U.S.A., Inc. | 1993-08-03 |
Legacy Summary#
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FDA Review#
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