SUSCEPTIBILITY DISK, CINOXACIN 100 MCG.
FDA 510(k) clearance K792349 · decided 1980-03-12
Clearance details
- K-number
- K792349
- Device name
- SUSCEPTIBILITY DISK, CINOXACIN 100 MCG.
- Applicant
- Pfizer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-11-19
- Decision date
- 1980-03-12
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- JNT
- Device class
- 1
- Regulation number
- 862.1575
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, 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 |
|---|---|---|
| ZITHROMAX (K922792) | Difco Laboratories, Inc. | 1992-07-30 |
| PHOSPHOLIPID REAGENT SET (K914040) | Sterling Diagnostics, Inc. | 1991-10-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GELFOAM (absorbable gelatin gel, powder from abs. gel, sponge USP), GELFOAM (compressed absorbable gelatin sponge, USP), (N18286/S041) | Pfizer, Inc. | 2023-05-16 |
| (Gelfoam (absorbable gelatin) Sterile Sponge) (N18286/S040) | Pfizer, Inc. | 2022-06-24 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S039) | Pfizer, Inc. | 2021-07-08 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S038) | Pfizer, Inc. | 2021-05-07 |
| Gelfoam Sterile Sponge (N18286/S037) | Pfizer, Inc. | 2021-02-24 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S036) | Pfizer, Inc. | 2020-12-10 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S035) | Pfizer, Inc. | 2020-03-19 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S034) | Pfizer, Inc. | 2020-02-27 |