ANTINUCLEAR ANTIBODY TEST KIT— 510(k) K831927
Substantially EquivalentBreit Laboratories, Inc.
FDA 510(k) clearance K831927 for ANTINUCLEAR ANTIBODY TEST KIT, Substantially Equivalent on 1983-07-18. Applicant: Breit Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Breit Laboratories, Inc.
- Product code
- Code DAA
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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