Medical Device Manufacturer · US , Bogart , GA

Sealite Sciences, Inc.

11 submissions · 11 cleared · Since 1994
11
Total
11
Cleared
0
Denied

Sealite Sciences, Inc. — FDA 510(k) Submissions

Sealite Sciences, Inc. has submitted 11 FDA 510(k) premarket notifications since 1994, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Radioimmunoassay, Luteinizing Hormone, Radioimmunoassay, Follicle-stimulating Hormone, Radioimmunoassay, Prolactin (lactogen), Radioimmunoassay, Parathyroid Hormone, Ferritin, Antigen, Antiserum, Control . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY
K974551 · CEC Radioimmunoassay, Free... · Chemistry
Dec 1997 18d
SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY
K972761 · CFL Radioimmunoassay, Human... · Chemistry
Sep 1997 63d
SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY
K970612 · DBF Ferritin, Antigen,... · Immunology
Jun 1997 126d
AQUALITE INTACT PTH
K970483 · CEW Radioimmunoassay,... · Chemistry
Apr 1997 63d
SEALITE SCIENCES, INC. AQUALITE PROLACTIN
K970188 · CFT Radioimmunoassay,... · Chemistry
Feb 1997 34d
SEALITE SCIENCES AQUALITE FSH
K970085 · CGJ Radioimmunoassay,... · Chemistry
Feb 1997 35d
SEALITE SCIENCES, INC. AQUALITE LH
K964925 · CEP Radioimmunoassay,... · Chemistry
Jan 1997 44d
AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT
K942661 · JLW Radioimmunoassay,... · Chemistry
Jan 1995 225d
AQUALITE FSH
K943437 · CGJ Radioimmunoassay,... · Chemistry
Dec 1994 163d
SEALITE SCIENCE, INC. AQUALITE(R) LH
K943188 · CEP Radioimmunoassay,... · Chemistry
Oct 1994 107d
SEALITE SCIENCES INC.
K941983 · DHA System, Test, Human... · Chemistry
Aug 1994 115d
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