COULTER GAMMA-GT (GGT) REAGENT
FDA 510(k) clearance K901264 · decided 1990-04-16
Clearance details
- K-number
- K901264
- Device name
- COULTER GAMMA-GT (GGT) REAGENT
- Applicant
- Coulter Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-03-16
- Decision date
- 1990-04-16
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- JQB
- Device class
- 1
- Regulation number
- 862.1360
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hialeah, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.