RAICHEM(TM) SPIA(TM) IGG REAGENTS
FDA 510(k) clearance K894416 · decided 1989-08-01
Clearance details
- K-number
- K894416
- Device name
- RAICHEM(TM) SPIA(TM) IGG REAGENTS
- Applicant
- Reagents Applications, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-17
- Decision date
- 1989-08-01
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- KTO
- Device class
- 1
- Regulation number
- 866.5530
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, 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 |
|---|---|---|
| KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT (K854483) | Kallestad Laboratories, Inc. | 1985-12-11 |
Recalls involving this device
No recalls on record reference this clearance.