ANTINUCLEAR ANTIBODY TEST KIT
FDA 510(k) clearance K831927 · decided 1983-07-18
Clearance details
- K-number
- K831927
- Device name
- ANTINUCLEAR ANTIBODY TEST KIT
- Applicant
- Breit Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-06-15
- Decision date
- 1983-07-18
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- DAA
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Breit Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ANA MICROZYME TEST SYS #1610 (K832675) | Clinical Sciences, Inc. | 1983-09-12 |
| IP SPECIFIC G (K830005) | Diagnostic Reagent Tech. | 1983-06-02 |
| ANAZYME ANA PEROXIDASE TEST SYSTEM (K822911) | Clinical Sciences, Inc. | 1982-10-22 |
| INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL (K791749) | Clinical Sciences, Inc. | 1979-10-17 |
Recalls involving this device
No recalls on record reference this clearance.