Company ยท US
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FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2008. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 2 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 2 |
| LAS | Drug Specific Control Materials | 2 |
| DIF | Drug Mixture Control Materials | 1 |
| GIL | Plasma, Fibrinogen Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 30, 2008 | K072257 | MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL More Diagnostics | LAS |
| Mar 18, 2005 | K050125 | RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 More Diagnostics | JJY |
| Aug 21, 1998 | K982845 | CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 More Diagnostics | JJT |
| Mar 16, 1998 | K980331 | IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S More Diagnostics | DIF |
| Aug 29, 1997 | K972976 | CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL More Diagnostics | JJT |
| Apr 17, 1997 | K970778 | LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 More Diagnostics | JJX |
| Aug 24, 1995 | K946193 | FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 More Diagnostics | GIL |
| Jun 15, 1995 | K943571 | MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS More Diagnostics | DAP |
| Jun 6, 1995 | K944999 | SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 More Diagnostics | JJX |
| Jul 28, 1994 | K941876 | WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2 More Diagnostics | JJY |
| Jul 28, 1994 | K941698 | SERUM VOLATILES CONTROL - LEVELS 1 AND 2 More Diagnostics | JJY |
| Nov 2, 1993 | K932657 | FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 More Diagnostics | DAP |
| Oct 28, 1993 | K932660 | LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2 More Diagnostics | JJX |
| Jul 28, 1993 | K932659 | MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM More Diagnostics | JJX |
| Jul 28, 1993 | K932658 | CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3 More Diagnostics | JJX |
| Jul 26, 1993 | K932662 | CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL More Diagnostics | LAS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||