Panels › Immunology › Product code DDS · Class 1
Prealbumin, Fitc, Antigen, Antiserum, Control
Regulation 866.5060
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DDS
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Instruments, Inc. | 2 | 0 |
| Hemagen Diagnostics, Inc. | 1 | 0 |
| Incstar Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 1997 | K972812 | RAICHEM PREALBUMIN SPIA Hemagen Diagnostics, Inc. | DDS |
| May 9, 1997 | K964781 | IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT Beckman Instruments, Inc. | DDS |
| Jan 11, 1994 | K934966 | SPQ PAL CONTROL LEVEL II Incstar Corp. | DDS |
| Jan 24, 1986 | K854811 | ICS PAB PREALBUMIN REAGENT TEST KIT Beckman Instruments, Inc. | DDS |
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