Panels › Hematology › Product code LGO · Class 1
Test, Leukocyte Typing
Regulation 864.7675
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LGO
| Company | 510(k)s | Recalls |
|---|---|---|
| Hyland Therapeutic Div., Travenol Laboratories | 2 | 0 |
| Calbiochem-Behring Corp. | 1 | 0 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 1 | 0 |
| Molecular Biosystems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 23, 1990 | K894947 | PLATELIA TOXO IGG KIT Kallestad Diag, A Div. of Erbamont, Inc. | LGO |
| Aug 12, 1988 | K874544 | SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT Molecular Biosystems, Inc. | LGO |
| Aug 3, 1979 | K791118 | HLA CONTROL SERA Calbiochem-Behring Corp. | LGO |
| Apr 6, 1977 | K761009 | LYMPHOCYTE TYPING, POSITIVE CONTROL Hyland Therapeutic Div., Travenol Laboratories | LGO |
| Apr 6, 1977 | K761008 | LYMPHOCYTE TYPING, NEGATIVE CONTROL Hyland Therapeutic Div., Travenol Laboratories | LGO |
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