AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC
FDA 510(k) clearance K822809 · decided 1982-11-22
Clearance details
- K-number
- K822809
- Device name
- AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC
- Applicant
- General Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1982-09-20
- Decision date
- 1982-11-22
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- JTN
- Device class
- 2
- Regulation number
- 866.1620
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch General Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.