FDA Product Code
FDA Product Code CFE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1445
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K100307 | GELSCAN, MODEL 1206 | Sebia | 2010-08-31 | Traditional | PDF ↗ |
| K022455 | SPIFE LD-12 KIT, MODEL 3338 | Helena Laboratories | 2002-10-01 | Traditional | PDF ↗ |
| K020467 | SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 | Helena Laboratories | 2002-03-29 | Traditional | PDF ↗ |
| K970477 | HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT | Sebia | 1997-03-10 | Traditional | PDF ↗ |
| K940224 | CARDIO REP LD | Helena Laboratories | 1994-08-17 | Traditional | PDF ↗ |
| K921455 | ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1992-04-29 | Traditional | PDF ↗ |
| K905861 | ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH | E.I. Dupont DE Nemours & Co., Inc. | 1991-02-06 | Traditional | PDF ↗ |
| K894081 | ROCHO ISOMUNE - LD | Roche Diagnostic Systems, Inc. | 1989-08-31 | Traditional | PDF ↗ |
| K892818 | REP(TM) LD-2 STAT KIT, CAT. NO. 3078 | Helena Laboratories | 1989-06-20 | Traditional | PDF ↗ |
| K874142 | TITAN GEL REP LDH-30 HV | Helena Laboratories | 1987-11-24 | Traditional | PDF ↗ |
| K874145 | TITAN GEL REP LDH-6 HV | Helena Laboratories | 1987-11-24 | Traditional | PDF ↗ |
| K874143 | TITAN GEL REP LDH-12 HV | Helena Laboratories | 1987-11-23 | Traditional | PDF ↗ |
| K873386 | TITAN GEL LDH REP SYSTEM | Helena Laboratories | 1987-10-20 | Traditional | PDF ↗ |
| K861750 | CK/LD BUFFER (CAT. NO. 5808) | Helena Laboratories | 1986-05-29 | Traditional | PDF ↗ |
| K850210 | ISOENZYME TEST LD-1 | Sclavo, Inc. | 1985-03-29 | Traditional | PDF ↗ |
| K842669 | TITAN GEL ISO DOT LDH KIT | Helena Laboratories | 1984-11-09 | Traditional | PDF ↗ |
| K841433 | CORNING LACTATE DEHYDROPHORETIC ASSAY | Corning Medical & Scientific | 1984-05-16 | Traditional | PDF ↗ |
| K832314 | CARDIZYME PLUS LD #65094/93 | Em Industries, Inc. | 1983-09-01 | Traditional | PDF ↗ |
| K830872 | TITAN GEL LDH ISO-ENZYME CONTROL | Helena Laboratories | 1983-04-12 | Traditional | PDF ↗ |
| K802628 | PARAGON ELECTROPHORESIS LACTATE REAG.KIT | Beckman Instruments, Inc. | 1980-12-11 | Traditional | PDF ↗ |
| K800568 | TRANSPHOR TM LD LACTATE DEHYDROGENASE | Corning Medical & Scientific | 1980-04-04 | Traditional | PDF ↗ |
| K791373 | ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS | Hoffmann-La Roche, Inc. | 1979-10-26 | Traditional | PDF ↗ |
| K791827 | LDH CLINI GEL KIT | Clinical Sciences, Inc. | 1979-10-01 | Traditional | PDF ↗ |
| K791656 | ENZYME STABILIZING REAGENT (ESR) | Electrophoresis Corp. of America | 1979-09-17 | Traditional | PDF ↗ |
| K791657 | LDH ISOENZYME REAGENT | Electrophoresis Corp. of America | 1979-09-17 | Traditional | PDF ↗ |
| K790311 | LDH ISOENZYME REAGENT | Electrophoresis Corp. | 1979-03-21 | Traditional | PDF ↗ |
| K781125 | LDH ISOENZYME REAGENT | Electrophoresis Corp. of America | 1978-08-10 | Traditional | PDF ↗ |
| K780080 | LACTATE DEHYDROGENASE COLORIMETRIC SUB. | Corning Medical & Scientific | 1978-02-07 | Traditional | PDF ↗ |
Product code CFE · Class II · Clinical Chemistry. Data: openFDA.