Medical Device Manufacturer · US , Mchenry , IL

Helena Laboratories - FDA 510(k) Cleared Devices

280 submissions · 280 cleared · Since 1978

280

Total

280

Cleared

0

Denied

122 devices

26-50 of 122

Cleared Aug 03, 1993

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

Chemistry · 193d

Cleared Apr 20, 1993

CARDIO REP CK ISOENZYME KIT - 3310

Chemistry · 50d

Cleared Apr 12, 1993

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

Chemistry · 76d

Cleared Dec 28, 1992

REP E-Z CK-30 ISOENZYME KIT

Chemistry · 42d

Cleared Sep 23, 1992

TITAN GEL ALKALINE PHOSPHATASE (HR)

Chemistry · 174d

Cleared Aug 18, 1992

REP SPE PLUS (PONCEAU S) SYSTEM

Chemistry · 106d

Cleared Jul 23, 1992

REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175

Chemistry · 83d

Cleared Jun 19, 1992

KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024

Chemistry · 112d

Cleared May 07, 1992

KEMTROL SERUM CONTROL-ABNORMAL

Chemistry · 69d

Cleared Nov 27, 1991

REP(R) SPE TEMPLATE 30, 16, & 8

Chemistry · 93d

Cleared Oct 30, 1991

REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172

Chemistry · 112d

Cleared Jul 30, 1991

REP ALP-15, 8, & 4 KITS

Chemistry · 50d

Cleared Jul 17, 1991

REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165

Chemistry · 82d

Cleared Apr 16, 1991

REP SPE PLUS (ACID BLUE) SYSTEM

Chemistry · 13d

Cleared Nov 09, 1990

REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM

Chemistry · 70d

Cleared Jun 12, 1990

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

Chemistry · 76d

Cleared Feb 26, 1990

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

Chemistry · 40d

Cleared Feb 16, 1990

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

Chemistry · 114d

Cleared Jan 11, 1990

REP(TM) SPE PLUS-30 PROCEDURES

Chemistry · 52d

Cleared Nov 17, 1989

Chemistry · 207d

Cleared Oct 25, 1989

GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104

Chemistry · 49d

Cleared Sep 13, 1989

REP TM SPE (PONCEAU S) PROCEDURES

Chemistry · 51d

Cleared Aug 31, 1989

REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187

Chemistry · 48d

Cleared Jul 20, 1989

REP(TM) CK-2 STAT KIT, CAT. NO. 3074

Chemistry · 87d

Cleared Jun 20, 1989

REP(TM) LD-2 STAT KIT, CAT. NO. 3078

Chemistry · 64d

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