Atlas FDA

SPIFE CHOLESTEROL PROFILE KIT

FDA 510(k) clearance K000603 · decided 2000-04-17

Clearance details

K-number
K000603
Device name
SPIFE CHOLESTEROL PROFILE KIT
Applicant
Helena Laboratories
Decision
Substantially Equivalent
Date received
2000-02-23
Decision date
2000-04-17
Days to decision
54 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.

RecordFirmDate
SPIFE LIPPOROTEIN-12, MODEL 3344 (K022333)Helena Laboratories2002-08-15
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 (K022053)Sebia2002-07-12
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)Morax2002-01-17
SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 (K013466)Helena Laboratories2001-12-21
LIPOPRINT SYSTEM, LDL SUBFRACTIONS (K010337)Quantimetrix Corp.2001-07-25
REP CHOLESTEROL PROFILE KIT (K992971)Helena Laboratories1999-10-18
HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 (K974854)Morax1998-10-07
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL (K980650)Helena Laboratories1998-05-01
MACRALP(A) ENZYME IMMUNOASSAY KIT (K971157)Strategic Diagnostics, Inc.1998-04-15
REP 3 QUTO-FLUR CHOLESTEROL-30 (K962914)Helena Laboratories1997-01-13
REP FLUR CHOLESTEROL-60 KIT (K964471)Helena Laboratories1996-12-23

Recalls involving this device

No recalls on record reference this clearance.