MODIFICATION TO: PREMIER PLATINUM HPSA
FDA 510(k) clearance K983255 · decided 1998-12-17
Clearance details
- K-number
- K983255
- Device name
- MODIFICATION TO: PREMIER PLATINUM HPSA
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-15
- Decision date
- 1998-12-17
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- LYR
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shippi recall (Z-0465-03) | Meridian Bioscience Inc | 2003-01-23 |