OPTIMATE IGA TEST
FDA 510(k) clearance K841815 · decided 1984-06-01
Clearance details
- K-number
- K841815
- Device name
- OPTIMATE IGA TEST
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-05-01
- Decision date
- 1984-06-01
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- CZN
- 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 |
|---|---|---|
| TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER (K891683) | Helena Laboratories | 1989-04-12 |
| QUANTIMETRIC PLUS C3 REAGENT KIT (K855011) | Kallestad Laboratories, Inc. | 1986-02-26 |
| FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS (K832262) | Gelco Diagnostics, Inc. | 1983-10-31 |
| GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC (K832257) | Gelco Diagnostics, Inc. | 1983-10-28 |
| RABBIT ANTISERUM TO HUMAN IGA (K831909) | Dako Corp. | 1983-07-18 |
| FIAX IGA TEST KIT (K831607) | Intl. Diagnostic Technology | 1983-06-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOSTATOR GLUCOSE CONTROLLER (P800032/S001) | Miles Laboratories, Inc. | 1983-06-02 |
| BIOSTATOR GLUCOSE CONTROLLER (P800032) | Miles Laboratories, Inc. | 1981-05-28 |