Medical Device Manufacturer · US , Bogart , GA

Sealite Sciences, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1994

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sealite Sciences, Inc. Chemistry ✕

10 devices

1-10 of 10

Cleared Dec 22, 1997

SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY

Chemistry · 18d

Cleared Sep 25, 1997

SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY

Chemistry · 63d

Cleared Apr 14, 1997

AQUALITE INTACT PTH

Chemistry · 63d

Cleared Feb 20, 1997

SEALITE SCIENCES, INC. AQUALITE PROLACTIN

Chemistry · 34d

Cleared Feb 14, 1997

SEALITE SCIENCES AQUALITE FSH

Chemistry · 35d

Cleared Jan 22, 1997

SEALITE SCIENCES, INC. AQUALITE LH

Chemistry · 44d

Cleared Jan 17, 1995

AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT

Chemistry · 225d

Cleared Dec 28, 1994

Chemistry · 163d

Cleared Oct 20, 1994

SEALITE SCIENCE, INC. AQUALITE(R) LH

Chemistry · 107d

Cleared Aug 18, 1994

SEALITE SCIENCES INC.

Chemistry · 115d