SPIFE URINE IFE
FDA 510(k) clearance K982639 · decided 1998-11-04
Clearance details
- K-number
- K982639
- Device name
- SPIFE URINE IFE
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1998-07-29
- Decision date
- 1998-11-04
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- DAO
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Beaumont, TX, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM (K812487) | Dako Corp. | 1981-09-23 |
| GEMENI IGM ASSAY (K800450) | Electro-Nucleonics Laboratories, Inc. | 1980-04-24 |
| ANTISERUM TO HUMAN IGM (K790705) | Kent Laboratories, Inc. | 1979-04-12 |
Recalls involving this device
No recalls on record reference this clearance.