FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MIC-BIOPLATE INOCULATOR
K Number: K803092
·
Decision Dec 22, 1980
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
66
Review Days
14
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Basic Information
- Device Name
- MIC-BIOPLATE INOCULATOR
- K Number
- K803092
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pasco Laboratories, Inc.
- Date Received
- December 8, 1980
- Decision Date
- December 22, 1980
- Product Code
- JQW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Pasco Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042331 | PASCO MIC AND MIC/ID PANELS | Oct 7, 2004 | Substantially Equivalent |
| K041776 | PASCO MIC AND MIC/ID PANELS | Aug 3, 2004 | Substantially Equivalent |
| K041214 | PASCO MIC AND MIC/ID PANELS | Jun 7, 2004 | Substantially Equivalent |
| K033119 | PASCO MIC AND MIC/ID PANELS | Nov 18, 2003 | Substantially Equivalent |
| K031727 | PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN | Jul 30, 2003 | Substantially Equivalent |
| K031205 | PASCO MIC AND MIC/ID PANELS | Jun 13, 2003 | Substantially Equivalent |
| K031103 | PASCO MIC AND MIC/ID PANELS (ERTAPENEM) | Jun 12, 2003 | Substantially Equivalent |
| K030933 | PASCO MIC AND MIC/ID PANELS | May 1, 2003 | Substantially Equivalent |
| K030620 | PASCO MIC AND MIC/ID PANELS | Apr 14, 2003 | Substantially Equivalent |
| K020331 | PASCO MIC AND MIC/ID PANELS | Mar 20, 2002 | Substantially Equivalent |