FDA Product Code
FDA Product Code DDS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5060
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K972812 | RAICHEM PREALBUMIN SPIA | Hemagen Diagnostics, Inc. | 1997-08-28 | Traditional | PDF ↗ |
| K964781 | IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT | Beckman Instruments, Inc. | 1997-05-09 | Traditional | PDF ↗ |
| K934966 | SPQ PAL CONTROL LEVEL II | Incstar Corp. | 1994-01-11 | Traditional | PDF ↗ |
| K854811 | ICS PAB PREALBUMIN REAGENT TEST KIT | Beckman Instruments, Inc. | 1986-01-24 | Traditional | PDF ↗ |
Product code DDS · Class I · Immunology. Data: openFDA.