GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664
FDA 510(k) clearance K884988 · decided 1989-01-13
Clearance details
- K-number
- K884988
- Device name
- GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664
- Applicant
- Em Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-01
- Decision date
- 1989-01-13
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- JQB
- Device class
- 1
- Regulation number
- 862.1360
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Gibbstown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.