TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER
FDA 510(k) clearance K891683 · decided 1989-04-12
Clearance details
- K-number
- K891683
- Device name
- TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1989-03-22
- Decision date
- 1989-04-12
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- CZN
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Beaumont, TX, 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 |
|---|---|---|
| QUANTIMETRIC PLUS C3 REAGENT KIT (K855011) | Kallestad Laboratories, Inc. | 1986-02-26 |
| OPTIMATE IGA TEST (K841815) | Miles Laboratories, Inc. | 1984-06-01 |
| 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.