FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT
K Number: K935162
·
Decision Nov 10, 1994
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
25
Applicant Total
280
Review Days
377
Basic Information
- Device Name
- REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT
- K Number
- K935162
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- HELENA LABORATORIES
- Date Received
- October 29, 1993
- Decision Date
- November 10, 1994
- Product Code
- JHO
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JHO | Electrophoretic Separation, Lipoproteins | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JHO), ordered by most recent decision date.
SPIFE LIPPOROTEIN-12, MODEL 3344
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HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
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MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
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MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
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SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIPOPRINT SYSTEM, LDL SUBFRACTIONS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by HELENA LABORATORIES
| K Number | Device Name | ||
|---|---|---|---|
| K131479 | V8 SP NORMAL CONTROL, ABNORMAL CONTROL | Oct 7, 2013 | Substantially Equivalent |
| K100103 | SPECIALTY ASSAYED CONTROL-2 | Dec 15, 2010 | Substantially Equivalent |
| K061991 | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA | Feb 23, 2007 | Substantially Equivalent |
| K061069 | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 | Jul 6, 2006 | Substantially Equivalent |
| K061014 | ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP | May 10, 2006 | Substantially Equivalent |
| K050053 | HEMORAM/AGGRAM ANALYZER | Jul 11, 2005 | Substantially Equivalent |
| K024162 | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 | Feb 19, 2003 | Substantially Equivalent |
| K023761 | PLATELETWORKS, MODELS PW-A, PW-C | Feb 14, 2003 | Substantially Equivalent |
| K022757 | SPIFE CK KIT, MODEL 3332, 3333 | Oct 11, 2002 | Substantially Equivalent |
| K022455 | SPIFE LD-12 KIT, MODEL 3338 | Oct 1, 2002 | Substantially Equivalent |