Sealite Sciences, Inc.
Bogart, GA, US
Sealite Sciences, Inc. appears in FDA device records in Bogart, GA. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Sealite Sciences, Inc. between 1994 and 1997. The busiest year on record is 1997, with 7. The most recent is 1997, with 7.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 3 |
| 1995 | 1 |
| 1997 | 7 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K974551 | SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY | CEC | Substantially Equivalent | |
| K972761 | SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY | CFL | Substantially Equivalent | |
| K970612 | SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY | DBF | Substantially Equivalent | |
| K970483 | AQUALITE INTACT PTH | CEW | Substantially Equivalent | |
| K970188 | SEALITE SCIENCES, INC. AQUALITE PROLACTIN | CFT | Substantially Equivalent | |
| K970085 | SEALITE SCIENCES AQUALITE FSH | CGJ | Substantially Equivalent | |
| K964925 | SEALITE SCIENCES, INC. AQUALITE LH | CEP | Substantially Equivalent | |
| K942661 | AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT | JLW | Substantially Equivalent | |
| K943437 | AQUALITE FSH | CGJ | Substantially Equivalent | |
| K943188 | SEALITE SCIENCE, INC. AQUALITE(R) LH | CEP | Substantially Equivalent | |
| K941983 | SEALITE SCIENCES INC. | DHA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DBFFerritin, Antigen, Antiserum, Control
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CFLRadioimmunoassay, Human Growth Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- DHASystem, Test, Human Chorionic Gonadotropin
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain