FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MODEL 80 BC
K Number: K821414
·
Decision May 27, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
7
Review Days
15
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Basic Information
- Device Name
- MODEL 80 BC
- K Number
- K821414
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Western Laboratories Corp.
- Date Received
- May 12, 1982
- Decision Date
- May 27, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- Third Party
- N
Other Clearances by Western Laboratories Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K834024 | HEPARINOMETER | Jun 11, 1984 | Substantially Equivalent |
| K830468 | MODEL 200 | Apr 12, 1983 | Substantially Equivalent |
| K821834 | MODEL 100 BICARBONATE CONDUCTIVITY | Jul 2, 1982 | Substantially Equivalent |
| K821415 | MODEL 90 BC | May 27, 1982 | Substantially Equivalent |
| K801303 | MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST | Jul 28, 1980 | Substantially Equivalent |
| K780932 | MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT | Aug 31, 1978 | Substantially Equivalent |