FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AQUALITE FSH
K Number: K943437
·
Decision Dec 28, 1994
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
87
Applicant Total
11
Review Days
163
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Basic Information
- Device Name
- AQUALITE FSH
- K Number
- K943437
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sealite Sciences, Inc.
- Date Received
- July 18, 1994
- Decision Date
- December 28, 1994
- Product Code
- CGJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGJ), ordered by most recent decision date.
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PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112
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EARLYDETECT MENOPAUSE TEST FOR FSH
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GENUA MENOPAUSE MONITOR TEST KIT
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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 |
| K970612 | SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY | Jun 24, 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 |
| K943188 | SEALITE SCIENCE, INC. AQUALITE(R) LH | Oct 20, 1994 | Substantially Equivalent |
| K941983 | SEALITE SCIENCES INC. | Aug 18, 1994 | Substantially Equivalent |