Helena Laboratories - FDA 510(k) Cleared Devices

Cleared Apr 16, 1991

HELENA THROMBOPLASTIN REAGENT WITH DILUENT

K905807 · GJS

Hematology · 110d

Cleared Apr 16, 1991

REP SPE PLUS (ACID BLUE) SYSTEM

K911468 · CEF

Chemistry · 13d

Cleared Feb 27, 1991

HELENA THROMBOPLASTIN REAGENT, MODIFICATION

K905857 · GJS

Hematology · 75d

Cleared Feb 11, 1991

AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183

K905673 · GGN

Hematology · 55d

Cleared Jan 18, 1991

FREE PROTEIN S REAGENT CAT. NO. 5363

K904247 · GGP

Hematology · 126d

Cleared Jan 03, 1991

TITAN GEL

K905149 · DAH

Immunology · 49d

Cleared Nov 09, 1990

REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM

K904035 · LBT

Chemistry · 70d

Cleared Jun 15, 1990

COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581

K901414 · LCP

Hematology · 81d

Cleared Jun 15, 1990

CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE

K902083 · GJT

Hematology · 39d

Cleared Jun 12, 1990

REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO)

K901463 · JQJ

Chemistry · 76d

Cleared Jun 06, 1990

REP(R) IMMUNOFIX

K901805 · DAH

Immunology · 47d

Cleared May 25, 1990

CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430

K901380 · GKP

Hematology · 64d

Cleared May 23, 1990

REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)

K901143 · JBD

Hematology · 72d

Cleared Mar 23, 1990

TIP TOP(R) DISPENSER CAPS

K896670 · GJW

Hematology · 116d

Cleared Mar 15, 1990

PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359

K896174 · GGP

Hematology · 141d

Cleared Feb 27, 1990

TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046

K900422 · CZP

Immunology · 28d

Cleared Feb 26, 1990

REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175

K900251 · CEF

Chemistry · 40d

Cleared Feb 16, 1990

REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083

K896170 · JHT

Chemistry · 114d

Cleared Feb 05, 1990

PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357

K897136 · GGP

Hematology · 40d

Cleared Jan 29, 1990

REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210)

K900017 · JPK

Hematology · 27d

Cleared Jan 25, 1990

ROCKET REFERENCE PLASMA, CAT NO. 5188

K900019 · GGN

Hematology · 23d

Cleared Jan 11, 1990

REP(TM) SPE PLUS-30 PROCEDURES

K896572 · CFP

Chemistry · 52d

Cleared Nov 17, 1989

PROTOFLUOR Z

K893038 · JKJ

Chemistry · 207d

Cleared Oct 25, 1989

GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104

K895528 · JJX

Chemistry · 49d

Cleared Sep 13, 1989

REP TM SPE (PONCEAU S) PROCEDURES

K894585 · CEF

Chemistry · 51d