DDS
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prealbumin, Fitc, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5060
- Medical specialty
- Immunology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RAICHEM PREALBUMIN SPIA (K972812) | Hemagen Diagnostics, Inc. | 1997-08-28 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT (K964781) | Beckman Instruments, Inc. | 1997-05-09 |
| SPQ PAL CONTROL LEVEL II (K934966) | Incstar Corp. | 1994-01-11 |
| ICS PAB PREALBUMIN REAGENT TEST KIT (K854811) | Beckman Instruments, Inc. | 1986-01-24 |
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Every clearance here is in the API, with alerts when new ones post.