Panels › Immunology › Product code DEL · Class 1
Lipoprotein X, Antigen, Antiserum, Control
Regulation 866.5590
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 DEL
| Company | 510(k)s | Recalls |
|---|---|---|
| Sigma Chemical Co. | 2 | 0 |
| Catachem, Inc. | 1 | 0 |
| Medical Marketing Consultants, Inc. | 1 | 0 |
| Roche Diagnostics Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 15, 2001 | K013278 | TINA-QUANT APOLIPOPROTEIN A-1 VER.2 Roche Diagnostics Corp. | DEL |
| Apr 26, 1990 | K901675 | APOLIPOPROTEIN A-I (APO A-I) Sigma Chemical Co. | DEL |
| Mar 2, 1990 | K900124 | APOLIPOPROTEIN B (APO B) Sigma Chemical Co. | DEL |
| Oct 6, 1989 | K895160 | ORTHO *APO A-1 ELISA TEST SYSTEM Medical Marketing Consultants, Inc. | DEL |
| Jun 21, 1989 | K893885 | BACTON TM, BASIC TM, APO A-I REAGENT Catachem, Inc. | DEL |
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