510(k) K831927
- Device
- ANTINUCLEAR ANTIBODY TEST KIT
- Applicant
- BREIT LABORATORIES, INC.
- 510(k) number
- K831927
- Product code
- DAA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-07-18
- Date received
- 1983-06-15
- Regulation
- 866.5510
- Classification name
- Igg, Peroxidase, Antigen, Antiserum, 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#
- 3019906
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DAA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832675 | ANA MICROZYME TEST SYS #1610 | Clinical Sciences, Inc. | 1983-09-12 |
| K830005 | IP SPECIFIC G | Diagnostic Reagent Tech. | 1983-06-02 |
| K822911 | ANAZYME ANA PEROXIDASE TEST SYSTEM | Clinical Sciences, Inc. | 1982-10-22 |
| K791749 | INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL | Clinical Sciences, Inc. | 1979-10-17 |
Legacy Summary#
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FDA Review#
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