FDA 510(k)
Substantially Equivalent
🇺🇸 United States
DIGITAL RADIOGRAPHY SYSTEM
K Number: K827289
·
Decision Apr 21, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
28
Review Days
22
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Basic Information
- Device Name
- DIGITAL RADIOGRAPHY SYSTEM
- K Number
- K827289
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Technology, Inc.
- Date Received
- March 30, 1982
- Decision Date
- April 21, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
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|---|---|---|---|
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| K891542 | EBNA-CHECK(TM) TEST KIT | Jun 20, 1989 | Substantially Equivalent |
| K890819 | HSV-CHECK(TM) TEST KIT | Jun 20, 1989 | Substantially Equivalent |
| K871373 | EBV-CHECK(TM) TEST KIT (IGG) | Jun 25, 1987 | Substantially Equivalent |
| K864128 | CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT | Apr 29, 1987 | Substantially Equivalent |
| K863408 | EBV/VCA-CHECK(TM) ANTIGEN SLIDES | Nov 28, 1986 | Substantially Equivalent |
| K860586 | PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS | May 7, 1986 | Substantially Equivalent |
| K860166 | PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 | Apr 4, 1986 | Substantially Equivalent |