FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
A FLUOROMETER
K Number: K813540
·
Decision Dec 31, 1981
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
39
Review Days
10
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Basic Information
- Device Name
- A FLUOROMETER
- K Number
- K813540
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2560
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- American Diagnostic Corp.
- Date Received
- December 21, 1981
- Decision Date
- December 31, 1981
- Product Code
- KHO
- 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 |
|---|---|---|---|
| KHO | Fluorometer, For Clinical Use | FDA class 1 | Clinical Chemistry |
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| K060321 | ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK | May 15, 2006 | Substantially Equivalent |
| K012304 | ADC 656 ELECTRONIC STETHOSCOPE | Nov 1, 2001 | Substantially Equivalent |
| K962655 | ANEROID AND MERCURIAL SPHYGMOMANOMETERS | Jan 27, 1997 | Substantially Equivalent |
| K940686 | ELECTRONIC THERMOMETERS | Jul 8, 1994 | Substantially Equivalent |
| K935944 | PROSCOPES AND ADSCOPES | Mar 3, 1994 | Substantially Equivalent |
| K932145 | COAGULATION REFERENCE PLASMA, NORMAL | Oct 18, 1993 | Substantially Equivalent |
| K894169 | BIOTEL MICROALBUMINURIA (TM) | Sep 18, 1989 | Substantially Equivalent |
| K893608 | ACTICHROME ATIII KIT | Jun 23, 1989 | Substantially Equivalent |