FDA 510(k) Applications Submitted by PAT FRANKS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K960571 |
02/08/1996 |
RAPID ELECTROPHORESIS ANALYZER |
HELENA LABORATORIES |
| K980650 |
02/19/1998 |
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL |
HELENA LABORATORIES |
| K980671 |
02/20/1998 |
COLOSCREEN-ES |
HELENA LABORATORIES |
| K010617 |
03/01/2001 |
SPIFE IFE CALIBRATOR AND CONTROL KIT |
HELENA LABORATORIES |
| K990998 |
03/25/1999 |
POLYSLIT IFE KIT |
HELENA LABORATORIES |
| K961908 |
05/16/1996 |
THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 |
HELENA LABORATORIES |
| K952321 |
05/18/1995 |
PORCINE FACTOR VIII;C REAGENT |
HELENA LABORATORIES |
| K952668 |
06/12/1995 |
CHROM Z-F:VIII, CAT. NO. 5241 |
HELENA LABORATORIES |
| K952667 |
06/12/1995 |
CHROM Z-HEPARIN, CAT. NO 5242 |
HELENA LABORATORIES |
| K952666 |
06/12/1995 |
CHROM Z-PROTEIN C, CAT. NO. 5243 |
HELENA LABORATORIES |
| K972274 |
06/18/1997 |
SPIFE |
HELENA LABORATORIES |
| K992199 |
06/30/1999 |
ACID HEMOGLOBIN KIT |
HELENA LABORATORIES |
| K982426 |
07/13/1998 |
SPIFE ALKALINE HEMOGLOBIN |
HELENA LABORATORIES |
| K962914 |
07/26/1996 |
REP 3 QUTO-FLUR CHOLESTEROL-30 |
HELENA LABORATORIES |
| K982639 |
07/29/1998 |
SPIFE URINE IFE |
HELENA LABORATORIES |
| K973040 |
08/14/1997 |
SPIFE IFE-6 |
HELENA LABORATORIES |
| K973316 |
09/03/1997 |
REP SPE VIS-60/40 KIT |
HELENA LABORATORIES |
| K003359 |
10/27/2000 |
COLOSCREEN-ES |
HELENA LABORATORIES |
| K964453 |
11/06/1996 |
REP 3 FLUR SPE-60 KIT |
HELENA LABORATORIES |
| K964471 |
11/07/1996 |
REP FLUR CHOLESTEROL-60 KIT |
HELENA LABORATORIES |
| K974609 |
12/10/1997 |
REP CHOLESTEROL PROFILE CONTROL-II |
HELENA LABORATORIES |
| K050053 |
01/10/2005 |
HEMORAM/AGGRAM ANALYZER |
HELENA LABORATORIES |
| K100103 |
01/13/2010 |
SPECIALTY ASSAYED CONTROL-2 |
HELENA LABORATORIES |
| K020467 |
02/12/2002 |
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 |
HELENA LABORATORIES |
| K020625 |
02/26/2002 |
SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 |
HELENA LABORATORIES |
| K020914 |
03/21/2002 |
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 |
HELENA LABORATORIES |
| K061014 |
04/13/2006 |
ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP |
HELENA LABORATORIES |
| K061069 |
04/17/2006 |
SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 |
HELENA LABORATORIES |
| K111369 |
05/16/2011 |
THE HELENA V8 IMMUNODISPLACEMENT KIT |
HELENA LABORATORIES UK LTD |
| K061991 |
07/13/2006 |
PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA |
HELENA LABORATORIES |
| K022333 |
07/18/2002 |
SPIFE LIPPOROTEIN-12, MODEL 3344 |
HELENA LABORATORIES |
| K022455 |
07/26/2002 |
SPIFE LD-12 KIT, MODEL 3338 |
HELENA LABORATORIES |
| K012723 |
08/15/2001 |
PLATELETWORKS |
HELENA LABORATORIES |
| K022757 |
08/20/2002 |
SPIFE CK KIT, MODEL 3332, 3333 |
HELENA LABORATORIES |
| K013078 |
09/14/2001 |
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 |
HELENA LABORATORIES |
| K013466 |
10/18/2001 |
SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 |
HELENA LABORATORIES |
| K023761 |
11/08/2002 |
PLATELETWORKS, MODELS PW-A, PW-C |
HELENA LABORATORIES |
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