Pb Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices

Cleared Jul 20, 1994

OPUS PROCAINAMIDE TEST SYSTEM

K934762 · LAR

Toxicology · 289d

Cleared Dec 22, 1993

OPUS DIGITOXIN

K935229 · DPG

Toxicology · 51d

Cleared Nov 22, 1993

OPUS NAPA

K934705 · LAN

Toxicology · 53d

Cleared Dec 11, 1992

OPUS(R) VANCOMYCIN

K924957 · LEH

Toxicology · 72d

Cleared Oct 15, 1992

OPUS(R) CK-MB

K924429 · JHY

Toxicology · 44d

Cleared Nov 07, 1991

OPUS(R) LH TEST SYSTEM

K913938 · CEP

Toxicology · 65d

Cleared Aug 16, 1991

OPUS(R) PROLACTIN TEST SYSTEM

K913280 · CFT

Toxicology · 23d

Cleared Jul 01, 1991

OPUS(R) TOBRAMYCIN

K911940 · LCR

Toxicology · 61d

Cleared Apr 16, 1991

OPUS FSH

K911409 · CGJ

Toxicology · 15d

Cleared Feb 21, 1991

OPUS GENTAMICIN

K905721 · LCQ

Toxicology · 62d

Cleared Feb 04, 1991

OPUS T3 TEST SYSTEM

K905410 · CDP

Toxicology · 63d

Cleared Jun 26, 1990

MODIFIED OPUS VALPROIC ACID TEST SYSTEM

K901538 · LEG

Toxicology · 85d