Panels › Hematology › Product code KSS · Class 1
Supplies, Blood-Bank
Regulation 864.9050
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KSS
| Company | 510(k)s | Recalls |
|---|---|---|
| Pre-Dent System | 3 | 0 |
| American Dade | 1 | 0 |
| Dade, Baxter Travenol Diagnostics, Inc. | 1 | 0 |
| U.S. Mfg. & Management, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 5, 1988 | K874436 | FLUID SAMPLING PACK U.S. Mfg. & Management, Inc. | KSS |
| Oct 27, 1981 | K812892 | S/P SERUM DROPPER PIPETS American Dade | KSS |
| Jul 14, 1980 | K801516 | PRE-DENT SYSTEM MODIFIED Pre-Dent System | KSS |
| Jul 14, 1980 | K801386 | PRE-DENT SYSTEM OR PRE-DENT II Pre-Dent System | KSS |
| Apr 24, 1980 | K800736 | PRE-DENT SYSTEM Pre-Dent System | KSS |
| Dec 30, 1976 | K761303 | IMMU-SAL IMMUNOHEMATOLOGICAL SALINE Dade, Baxter Travenol Diagnostics, Inc. | KSS |
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