FDA 510(k)
Substantially Equivalent
🇺🇸 United States
IDI GDR DATA REDUCTION SYSTEM
K Number: K780813
·
Decision Jun 28, 1978
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
7
Review Days
44
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Basic Information
- Device Name
- IDI GDR DATA REDUCTION SYSTEM
- K Number
- K780813
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Iso-Data, Inc.
- Date Received
- May 15, 1978
- Decision Date
- June 28, 1978
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
Other Clearances by Iso-Data, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K872429 | ISO-DATA 100 SERIES GAMMA COUNTER | Aug 21, 1987 | Substantially Equivalent |
| K872430 | ISO-DATA 500 SERIES GAMMA COUNTER | Aug 21, 1987 | Substantially Equivalent |
| K843434 | ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. | Oct 5, 1984 | Substantially Equivalent |
| K843365 | ISO-DATA IMMUNOASSAY NETWORK SYSTEM | Sep 27, 1984 | Substantially Equivalent |
| K810631 | DPM CALCULATOR | Mar 27, 1981 | Substantially Equivalent |
| K780790 | IDI 200 GAMMA COUNTER | Jun 22, 1978 | Substantially Equivalent |