510(k) K894366
- Device
- Rep Hdl-8 Kit, No. 3188, Rep Hdl-16 Kit, No. 3187
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K894366
- Product code
- LBT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-08-31
- Date received
- 1989-07-14
- Regulation
- 862.1475
- Classification name
- Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAT FRANKS
- Address
- 1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704
FDA Registration Numbers#
- 3010830834
- 8023024
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LBT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000568 | HDL CHOLESTEROL PLUS | Roche Diagnostics Corp. | 2000-08-04 |
| K990250 | HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 | Morax | 1999-06-18 |
| K972015 | HYDRAGEL 7,15,30, CHOL-HDL KIT | Morax | 1997-10-27 |
| K904035 | REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM | Helena Laboratories | 1990-11-09 |
| K882368 | REP HDL ELECTROPHORESIS METHOD | Helena Laboratories | 1988-08-08 |
| K873547 | TITAN GEL HDL CHOLESTEROL KIT | Helena Laboratories | 1987-10-02 |
| K790791 | ELECTROPHORESIS REAGENT SET, HDL | Gelman Sciences, Inc. | 1979-06-15 |