510(k) K874145
- Device
- Titan Gel Rep Ldh-6 Hv
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K874145
- Product code
- CFE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-11-24
- Date received
- 1987-10-13
- Regulation
- 862.1445
- Classification name
- Electrophoretic, Lactate Dehydrogenase Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ERIC PETERSEN
- Address
- 1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704
FDA Registration Numbers#
- 8023024
- 1618982
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CFE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100307 | GELSCAN, MODEL 1206 | Sebia | 2010-08-31 |
| K022455 | SPIFE LD-12 KIT, MODEL 3338 | Helena Laboratories | 2002-10-01 |
| K020467 | SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 | Helena Laboratories | 2002-03-29 |
| K970477 | HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT | Sebia | 1997-03-10 |
| K940224 | CARDIO REP LD | Helena Laboratories | 1994-08-17 |
| K921455 | ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1992-04-29 |
| K905861 | ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH | E.I. Dupont DE Nemours & Co., Inc. | 1991-02-06 |
| K894081 | ROCHO ISOMUNE - LD | Roche Diagnostic Systems, Inc. | 1989-08-31 |
| K892818 | REP(TM) LD-2 STAT KIT, CAT. NO. 3078 | Helena Laboratories | 1989-06-20 |
| K874142 | TITAN GEL REP LDH-30 HV | Helena Laboratories | 1987-11-24 |
| K874143 | TITAN GEL REP LDH-12 HV | Helena Laboratories | 1987-11-23 |
| K873386 | TITAN GEL LDH REP SYSTEM | Helena Laboratories | 1987-10-20 |
| K861750 | CK/LD BUFFER (CAT. NO. 5808) | Helena Laboratories | 1986-05-29 |
| K850210 | ISOENZYME TEST LD-1 | Sclavo, Inc. | 1985-03-29 |
| K842669 | TITAN GEL ISO DOT LDH KIT | Helena Laboratories | 1984-11-09 |