CFE — Electrophoretic, Lactate Dehydrogenase Isoenzymes Class II
FDA product code CFE covers "Electrophoretic, Lactate Dehydrogenase Isoenzymes", a Class II medical device regulated under 21 CFR 862.1445. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CFE
- Device Class
- Class II
- Regulation Number
- 862.1445
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K100307 | sebia | GELSCAN, MODEL 1206 | August 31, 2010 |
| K022455 | helena laboratories | SPIFE LD-12 KIT, MODEL 3338 | October 1, 2002 |
| K020467 | helena laboratories | SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 | March 29, 2002 |
| K970477 | sebia | HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT | March 10, 1997 |
| K940224 | helena laboratories | CARDIO REP LD | August 17, 1994 |
| K921455 | e.i. dupont de nemours and co | ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD | April 29, 1992 |
| K905861 | e.i. dupont de nemours and co | ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH | February 6, 1991 |
| K894081 | roche diagnostic systems | ROCHO ISOMUNE - LD | August 31, 1989 |
| K892818 | helena laboratories | REP(TM) LD-2 STAT KIT, CAT. NO. 3078 | June 20, 1989 |
| K874145 | helena laboratories | TITAN GEL REP LDH-6 HV | November 24, 1987 |
| K874142 | helena laboratories | TITAN GEL REP LDH-30 HV | November 24, 1987 |
| K874143 | helena laboratories | TITAN GEL REP LDH-12 HV | November 23, 1987 |
| K873386 | helena laboratories | TITAN GEL LDH REP SYSTEM | October 20, 1987 |
| K861750 | helena laboratories | CK/LD BUFFER (CAT. NO. 5808) | May 29, 1986 |
| K850210 | sclavo | ISOENZYME TEST LD-1 | March 29, 1985 |
| K842669 | helena laboratories | TITAN GEL ISO DOT LDH KIT | November 9, 1984 |
| K841433 | corning medical and scientific | CORNING LACTATE DEHYDROPHORETIC ASSAY | May 16, 1984 |
| K832314 | em industries | CARDIZYME PLUS LD #65094/93 | September 1, 1983 |
| K830872 | helena laboratories | TITAN GEL LDH ISO-ENZYME CONTROL | April 12, 1983 |
| K802628 | beckman instruments | PARAGON ELECTROPHORESIS LACTATE REAG.KIT | December 11, 1980 |