FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY
K Number: K970612
·
Decision Jun 24, 1997
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
86
Applicant Total
11
Review Days
126
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Basic Information
- Device Name
- SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY
- K Number
- K970612
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sealite Sciences, Inc.
- Date Received
- February 18, 1997
- Decision Date
- June 24, 1997
- Product Code
- DBF
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DBF | Ferritin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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Other Clearances by Sealite Sciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974551 | SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY | Dec 22, 1997 | Substantially Equivalent |
| K972761 | SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY | Sep 25, 1997 | Substantially Equivalent |
| K970483 | AQUALITE INTACT PTH | Apr 14, 1997 | Substantially Equivalent |
| K970188 | SEALITE SCIENCES, INC. AQUALITE PROLACTIN | Feb 20, 1997 | Substantially Equivalent |
| K970085 | SEALITE SCIENCES AQUALITE FSH | Feb 14, 1997 | Substantially Equivalent |
| K964925 | SEALITE SCIENCES, INC. AQUALITE LH | Jan 22, 1997 | Substantially Equivalent |
| K942661 | AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT | Jan 17, 1995 | Substantially Equivalent |
| K943437 | AQUALITE FSH | Dec 28, 1994 | Substantially Equivalent |
| K943188 | SEALITE SCIENCE, INC. AQUALITE(R) LH | Oct 20, 1994 | Substantially Equivalent |
| K941983 | SEALITE SCIENCES INC. | Aug 18, 1994 | Substantially Equivalent |