ANA MICROZYME TEST SYS #1610
FDA 510(k) clearance K832675 · decided 1983-09-12
Clearance details
- K-number
- K832675
- Device name
- ANA MICROZYME TEST SYS #1610
- Applicant
- Clinical Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-09
- Decision date
- 1983-09-12
- Days to decision
- 34 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
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ANTINUCLEAR ANTIBODY TEST KIT (K831927) | Breit Laboratories, Inc. | 1983-07-18 |
| 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.