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

Cleared Jun 26, 1990

OPUS(TM) DIGOXIN TEST SYSTEM

K901547 · KXT

Toxicology · 84d

Cleared Jun 26, 1990

OPUS (TM) HCG

K901935 · JHI

Toxicology · 57d

Cleared Jun 12, 1990

MODIFIED OPUS PHENOBARBITAL TEST SYSTEM

K901537 · LET

Toxicology · 71d

Cleared Mar 19, 1990

OPUS T4 TEST SYSTEM

K897193 · KLI

Toxicology · 80d

Cleared Jan 11, 1990

OPUS PHENOBARBITAL TEST SYSTEM

K896861 · DLZ

Toxicology · 37d

Cleared Jan 02, 1990

OPUS CARBAMAZEPINE TEST SYSTEM

K896860 · KLT

Toxicology · 28d

Cleared Jan 02, 1990

OPUS PHENYTOIN TEST SYSTEM

K896868 · LGR

Toxicology · 26d

Cleared Aug 03, 1989

OPUS IMMUNOASSAY SYSTEM

K894159 · KHO

Toxicology · 50d

Cleared Dec 29, 1988

BEHRING POLAROID OPUS THEOPHYLLINE

K885044 · KLS

Toxicology · 24d