REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL
FDA 510(k) clearance K980650 · decided 1998-05-01
Clearance details
- K-number
- K980650
- Device name
- REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1998-02-19
- Decision date
- 1998-05-01
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- JHO
- 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 |
|---|---|---|
| SPIFE LIPPOROTEIN-12, MODEL 3344 (K022333) | Helena Laboratories | 2002-08-15 |
| HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 (K022053) | Sebia | 2002-07-12 |
| MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS (K013662) | Quantimetrix Corp. | 2002-03-08 |
| MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 (K012789) | Morax | 2002-01-17 |
| SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 (K013466) | Helena Laboratories | 2001-12-21 |
| LIPOPRINT SYSTEM, LDL SUBFRACTIONS (K010337) | Quantimetrix Corp. | 2001-07-25 |
| SPIFE CHOLESTEROL PROFILE KIT (K000603) | Helena Laboratories | 2000-04-17 |
| REP CHOLESTEROL PROFILE KIT (K992971) | Helena Laboratories | 1999-10-18 |
| HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 (K974854) | Morax | 1998-10-07 |
| MACRALP(A) ENZYME IMMUNOASSAY KIT (K971157) | Strategic Diagnostics, Inc. | 1998-04-15 |
| REP 3 QUTO-FLUR CHOLESTEROL-30 (K962914) | Helena Laboratories | 1997-01-13 |
| REP FLUR CHOLESTEROL-60 KIT (K964471) | Helena Laboratories | 1996-12-23 |
Recalls involving this device
No recalls on record reference this clearance.