QUANTAFLUOR FLUORESCENT TEST REAGENTS
FDA 510(k) clearance K813592 · decided 1982-01-18
Clearance details
- K-number
- K813592
- Device name
- QUANTAFLUOR FLUORESCENT TEST REAGENTS
- Applicant
- Kallestad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-28
- Decision date
- 1982-01-18
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- DHN
- Device class
- 2
- Regulation number
- 866.5100
- 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 |
|---|---|---|
| "BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN" recall (Z-3051-2011) | Bio-Rad Laboratories | 2011-08-22 |
| Kallestad (TM) Mouse Stomach/Kidney, catalog number 30443 - 8 wells, 48 tests. Product lab recall (Z-2429-2008) | Bio-Rad Laboratories | 2008-09-19 |