REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM
FDA 510(k) clearance K904035 · decided 1990-11-09
Clearance details
- K-number
- K904035
- Device name
- REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1990-08-31
- Decision date
- 1990-11-09
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- LBT
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Beaumont, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HDL CHOLESTEROL PLUS (K000568) | Roche Diagnostics Corp. | 2000-08-04 |
| 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 (K990250) | Morax | 1999-06-18 |
| HYDRAGEL 7,15,30, CHOL-HDL KIT (K972015) | Morax | 1997-10-27 |
| REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 (K894366) | Helena Laboratories | 1989-08-31 |
| REP HDL ELECTROPHORESIS METHOD (K882368) | Helena Laboratories | 1988-08-08 |
| TITAN GEL HDL CHOLESTEROL KIT (K873547) | Helena Laboratories | 1987-10-02 |
| ELECTROPHORESIS REAGENT SET, HDL (K790791) | Gelman Sciences, Inc. | 1979-06-15 |
Recalls involving this device
No recalls on record reference this clearance.