FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
APOLLO DENSITOMETER
K Number: K853734
·
Decision Sep 25, 1985
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
17
Applicant Total
4
Review Days
19
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Basic Information
- Device Name
- APOLLO DENSITOMETER
- K Number
- K853734
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2400
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Astral Medical Systems
- Date Received
- September 6, 1985
- Decision Date
- September 25, 1985
- Product Code
- JQT
- 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 |
|---|---|---|---|
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | FDA class 1 | Clinical Chemistry |
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