Panels › Clinical Chemistry › Product code CFE · Class 2
Electrophoretic, Lactate Dehydrogenase Isoenzymes
Regulation 862.1445
0510(k)s in 12 months (28 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in CFE
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 11 | 0 |
| Corning Medical & Scientific | 3 | 0 |
| Electrophoresis Corp. of America | 3 | 0 |
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 0 |
| Sebia | 2 | 0 |
| Beckman Instruments, Inc. | 1 | 0 |
| Clinical Sciences, Inc. | 1 | 0 |
| Electrophoresis Corp. | 1 | 0 |
| Em Industries, Inc. | 1 | 0 |
| Hoffmann-La Roche, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 31, 2010 | K100307 | GELSCAN, MODEL 1206 Sebia | CFE |
| Oct 1, 2002 | K022455 | SPIFE LD-12 KIT, MODEL 3338 Helena Laboratories | CFE |
| Mar 29, 2002 | K020467 | SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 Helena Laboratories | CFE |
| Mar 10, 1997 | K970477 | HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT Sebia | CFE |
| Aug 17, 1994 | K940224 | CARDIO REP LD Helena Laboratories | CFE |
| Apr 29, 1992 | K921455 | ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD E.I. Dupont DE Nemours & Co., Inc. | CFE |
| Feb 6, 1991 | K905861 | ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH E.I. Dupont DE Nemours & Co., Inc. | CFE |
| Aug 31, 1989 | K894081 | ROCHO ISOMUNE - LD Roche Diagnostic Systems, Inc. | CFE |
| Jun 20, 1989 | K892818 | REP(TM) LD-2 STAT KIT, CAT. NO. 3078 Helena Laboratories | CFE |
| Nov 24, 1987 | K874145 | TITAN GEL REP LDH-6 HV Helena Laboratories | CFE |
| Nov 24, 1987 | K874142 | TITAN GEL REP LDH-30 HV Helena Laboratories | CFE |
| Nov 23, 1987 | K874143 | TITAN GEL REP LDH-12 HV Helena Laboratories | CFE |
| Oct 20, 1987 | K873386 | TITAN GEL LDH REP SYSTEM Helena Laboratories | CFE |
| May 29, 1986 | K861750 | CK/LD BUFFER (CAT. NO. 5808) Helena Laboratories | CFE |
| Mar 29, 1985 | K850210 | ISOENZYME TEST LD-1 Sclavo, Inc. | CFE |
| Nov 9, 1984 | K842669 | TITAN GEL ISO DOT LDH KIT Helena Laboratories | CFE |
| May 16, 1984 | K841433 | CORNING LACTATE DEHYDROPHORETIC ASSAY Corning Medical & Scientific | CFE |
| Sep 1, 1983 | K832314 | CARDIZYME PLUS LD #65094/93 Em Industries, Inc. | CFE |
| Apr 12, 1983 | K830872 | TITAN GEL LDH ISO-ENZYME CONTROL Helena Laboratories | CFE |
| Dec 11, 1980 | K802628 | PARAGON ELECTROPHORESIS LACTATE REAG.KIT Beckman Instruments, Inc. | CFE |
| Apr 4, 1980 | K800568 | TRANSPHOR TM LD LACTATE DEHYDROGENASE Corning Medical & Scientific | CFE |
| Oct 26, 1979 | K791373 | ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS Hoffmann-La Roche, Inc. | CFE |
| Oct 1, 1979 | K791827 | LDH CLINI GEL KIT Clinical Sciences, Inc. | CFE |
| Sep 17, 1979 | K791657 | LDH ISOENZYME REAGENT Electrophoresis Corp. of America | CFE |
| Sep 17, 1979 | K791656 | ENZYME STABILIZING REAGENT (ESR) Electrophoresis Corp. of America | CFE |
| Mar 21, 1979 | K790311 | LDH ISOENZYME REAGENT Electrophoresis Corp. | CFE |
| Aug 10, 1978 | K781125 | LDH ISOENZYME REAGENT Electrophoresis Corp. of America | CFE |
| Feb 7, 1978 | K780080 | LACTATE DEHYDROGENASE COLORIMETRIC SUB. Corning Medical & Scientific | CFE |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.