MIC-BIOPLATE INOCULATOR
FDA 510(k) clearance K803092 · decided 1980-12-22
Clearance details
- K-number
- K803092
- Device name
- MIC-BIOPLATE INOCULATOR
- Applicant
- Pasco Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-12-08
- Decision date
- 1980-12-22
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- JQW
- Device class
- 1
- Regulation number
- 862.2750
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| IMPACT (K961694) | Matrix Technologies Corp. | 1996-06-21 |
| GENESIS (K953345) | Tecan U.S., Inc. | 1995-11-21 |
| MEDTEC AUTOBLOT 2000 (K951753) | Medtec, Inc. | 1995-10-17 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MIC ANTIBIOTIC TEST PANELS (N50494/S006) | Pasco Laboratories, Inc. | 1983-11-02 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S011) | Pasco Laboratories, Inc. | 1983-07-25 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S010) | Pasco Laboratories, Inc. | 1983-07-08 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S008) | Pasco Laboratories, Inc. | 1982-12-22 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S009) | Pasco Laboratories, Inc. | 1982-12-01 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S007) | Pasco Laboratories, Inc. | 1982-09-03 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S005) | Pasco Laboratories, Inc. | 1982-06-30 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S004) | Pasco Laboratories, Inc. | 1982-03-12 |