Helena Laboratories - FDA 510(k) Cleared Devices

Cleared Nov 10, 1994

REP DIRECT-SEP CHOLESTEROL-15 KIT

K935162 · JHO

Chemistry · 377d

Cleared Oct 31, 1994

AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328

K933086 · JCM

Hematology · 495d

Cleared Oct 07, 1994

SPECIALTY ASSAYED CONTROL-1

K941737 · GIZ

Hematology · 183d

Cleared Sep 14, 1994

SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)

K941860 · GGN

Hematology · 152d

Cleared Sep 09, 1994

REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222

K940679 · JHO

Chemistry · 212d

Cleared Aug 17, 1994

CARDIO REP LD

K940224 · CFE

Chemistry · 211d

Cleared Apr 20, 1994

HELENA THROMBOPLASTIN-MI REAGENT

K940310 · GJS

Hematology · 86d

Cleared Mar 22, 1994

COAGULATION A.R.P.

K933277 · GGN

Hematology · 264d

Cleared Oct 28, 1993

CARDIO REP RECOMBINANT CK ABNORMAL CONTROL

K932442 · JJT

Chemistry · 161d

Cleared Oct 18, 1993

CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323

K932768 · JIX

Chemistry · 132d

Cleared Aug 23, 1993

CASCADE M, CAT. NO. 1710

K931956 · GKP

Hematology · 125d

Cleared Aug 16, 1993

REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)

K931503 · JBD

Hematology · 144d

Cleared Aug 03, 1993

REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278

K930317 · CEF

Chemistry · 193d

Cleared Jul 06, 1993

REP ALKALINE HB-15 #3196,-8 #3197,-4 3198

K931465 · JBD

Hematology · 104d

Cleared Apr 27, 1993

TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067

K931247 · DAH

Immunology · 47d

Cleared Apr 20, 1993

CARDIO REP CK ISOENZYME KIT - 3310

K931050 · JHW

Chemistry · 50d

Cleared Apr 12, 1993

CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305

K930359 · JHT

Chemistry · 76d

Cleared Feb 12, 1993

OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376

K926222 · JPA

Hematology · 64d

Cleared Dec 28, 1992

REP E-Z CK-30 ISOENZYME KIT

K925801 · CGS

Chemistry · 42d

Cleared Dec 18, 1992

SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479

K924915 · JJY

Hematology · 80d

Cleared Nov 02, 1992

REP IMMUNOFIX

K923658 · CFF

Immunology · 102d

Cleared Sep 23, 1992

TITAN GEL ALKALINE PHOSPHATASE (HR)

K921578 · CIN

Chemistry · 174d

Cleared Aug 25, 1992

COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL

K923317 · JPD

Hematology · 49d

Cleared Aug 25, 1992

COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL

K923318 · JPD

Hematology · 49d

Cleared Aug 18, 1992

REP SPE PLUS (PONCEAU S) SYSTEM

K922053 · CEF

Chemistry · 106d