GC OIA
FDA 510(k) clearance K023947 · decided 2003-04-17
Clearance details
- K-number
- K023947
- Device name
- GC OIA
- Applicant
- Thermo Biostar, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-27
- Decision date
- 2003-04-17
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- LIR
- Device class
- 2
- Regulation number
- 866.3390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Louisville, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL (K882534) | Abbott Laboratories | 1988-07-12 |
| HYGEIA GC TEST (K881064) | Hygeia Sciences | 1988-06-02 |
Recalls involving this device
No recalls on record reference this clearance.