REFEREE BRAND CO-OXIMETER REAGENTS
FDA 510(k) clearance K830180 · decided 1983-04-08
Clearance details
- K-number
- K830180
- Device name
- REFEREE BRAND CO-OXIMETER REAGENTS
- Applicant
- Analytical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-18
- Decision date
- 1983-04-08
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- KHG
- Device class
- 2
- Regulation number
- 864.7500
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S010) | Analytical Products, Inc. | 1984-05-04 |
| API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S009) | Analytical Products, Inc. | 1984-04-24 |
| UNISCEPT(TM) (P830028/S001) | Analytical Products, Inc. | 1984-03-09 |
| UNISCEPT(TM) (P830028) | Analytical Products, Inc. | 1984-03-01 |
| API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S007) | Analytical Products, Inc. | 1983-11-25 |
| API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S008) | Analytical Products, Inc. | 1983-11-17 |
| OMNISCEPT(TM) KB SYSTEM (P800029/S005) | Analytical Products, Inc. | 1983-07-05 |
| API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S003) | Analytical Products, Inc. | 1982-06-18 |