ZITHROMAX
FDA 510(k) clearance K922792 · decided 1992-07-30
Clearance details
- K-number
- K922792
- Device name
- ZITHROMAX
- Applicant
- Difco Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-09
- Decision date
- 1992-07-30
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- JNT
- Device class
- 1
- Regulation number
- 862.1575
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Detroit, MI, 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 |
|---|---|---|
| PHOSPHOLIPID REAGENT SET (K914040) | Sterling Diagnostics, Inc. | 1991-10-30 |
| SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. (K792349) | Pfizer, Inc. | 1980-03-12 |
Recalls involving this device
No recalls on record reference this clearance.