Medical Device Manufacturer · US , Little Falls , NJ

Photec Diagnostics, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1985

Total

Cleared

Denied

Photec Diagnostics, Inc. has 12 FDA 510(k) cleared medical devices. Based in Little Falls, US.

Historical record: 12 cleared submissions from 1985 to 1990. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Photec Diagnostics, Inc. Filter by specialty or product code using the sidebar.

Photec Diagnostics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Photec Diagnostics, Inc.

12 devices

1-12 of 12

Cleared Feb 23, 1990

QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT

K897169 · CDT

Chemistry · 57d

Cleared Dec 12, 1989

D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.

K896329 · KLI

Chemistry · 40d

Cleared Aug 31, 1989

QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT

K894057 · LBS

Chemistry · 85d

Cleared Jun 16, 1989

D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN

K892224 · KHQ

Chemistry · 74d

Cleared Apr 26, 1989

QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD

K890027 · CHH

Chemistry · 112d

Cleared Apr 26, 1989

QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA

THEOPHYLLINE TEST KIT REF. #A874799

K880291 · LCA

Chemistry · 59d

Cleared Jan 24, 1986

APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1

K854875 · DER

Immunology · 51d

Cleared Aug 28, 1985

APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1

K853048 · DER

Immunology · 40d

Cleared Aug 22, 1985

APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN

K853174 · MSJ

Immunology · 23d

Cleared Jun 05, 1985

APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1

K851649 · DER

Immunology · 44d

Photec Diagnostics, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Photec Diagnostics, Inc.

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