FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ALLERGEN IMMUNOSORBENTS IP SPECIFIC E
K Number: K831496
·
Decision Aug 8, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
10
Review Days
90
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Basic Information
- Device Name
- ALLERGEN IMMUNOSORBENTS IP SPECIFIC E
- K Number
- K831496
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Reagent Tech.
- Date Received
- May 10, 1983
- Decision Date
- August 8, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- IM
- Third Party
- N
Other Clearances by Diagnostic Reagent Tech.
| K Number | Device Name | ||
|---|---|---|---|
| K843302 | NEW ALLERG. COATED MICROFILTER WELL STRI | Oct 4, 1984 | Substantially Equivalent |
| K832345 | POLYSTYRENE MICROTITER WELL IMMUNOSOR | Nov 25, 1983 | Substantially Equivalent |
| K832344 | POLYSTYRENE MICROTITER PLATE IMMUNO- | Nov 21, 1983 | Substantially Equivalent |
| K831984 | POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE | Nov 21, 1983 | Substantially Equivalent |
| K831774 | LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- | Jul 18, 1983 | Substantially Equivalent |
| K830005 | IP SPECIFIC G | Jun 2, 1983 | Substantially Equivalent |
| K830653 | POLYSTYRENE MICROTITER PLATE IMMUNOSORB | Apr 8, 1983 | Substantially Equivalent |
| K830495 | POLYSTYRENE MICROTITER PLATE IMMUNOSOR | Apr 5, 1983 | Substantially Equivalent |
| K821094 | IP SPECIFIC E | May 7, 1982 | Substantially Equivalent |