KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
FDA 510(k) clearance K792610 · decided 1980-02-22
Clearance details
- K-number
- K792610
- Device name
- KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
- Applicant
- Kallestad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-12-18
- Decision date
- 1980-02-22
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- DBL
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Kallestad (TM) Mouse Kidney. Product labeled "BIO-RAD Kallestad (TM) Mouse Kidney Substrat recall (Z-2430-2008) | Bio-Rad Laboratories | 2008-09-19 |