FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENSITOMETER 18, COMPUTING, AUTO.
K Number: K772325
·
Decision Jan 12, 1978
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
17
Applicant Total
11
Review Days
24
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Basic Information
- Device Name
- DENSITOMETER 18, COMPUTING, AUTO.
- K Number
- K772325
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2400
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Gelman Instrument Co.
- Date Received
- December 19, 1977
- Decision Date
- January 12, 1978
- 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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Other Clearances by Gelman Instrument Co.
| K Number | Device Name | ||
|---|---|---|---|
| K772075 | RADIAL IMMUNODIFFUSION KIT-COMPLEMENT | Feb 3, 1978 | Substantially Equivalent |
| K772076 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. | Feb 3, 1978 | Substantially Equivalent |
| K772080 | RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT | Feb 3, 1978 | Substantially Equivalent |
| K772077 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G | Feb 3, 1978 | Substantially Equivalent |
| K772074 | RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN | Feb 3, 1978 | Substantially Equivalent |
| K772079 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M | Feb 3, 1978 | Substantially Equivalent |
| K772073 | RADIAL IMMUNODIFFUSION KIT-COMP. 3 | Feb 3, 1978 | Substantially Equivalent |
| K772078 | RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN | Feb 3, 1978 | Substantially Equivalent |
| K771812 | LIPPOPROTEIN ELECTROPHORESIS REAGENT SET | Oct 18, 1977 | Substantially Equivalent |
| K770155 | ALKALINE PHOSPHATASE ISOYZME REAGENT SET | Jan 31, 1977 | Substantially Equivalent |