PRECEPT CEFOPERAZONE
FDA 510(k) clearance K853596 · decided 1985-09-16
Clearance details
- K-number
- K853596
- Device name
- PRECEPT CEFOPERAZONE
- Applicant
- Austin Biological Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1985-08-27
- Decision date
- 1985-09-16
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- LTW
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Austin, TX, 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 |
|---|---|---|
| MIC-CONCEPT SYSTEM (K852613) | Microtech Medical Systems, Inc. | 1985-09-20 |
| PRECEPT CEFTRIAXONE (K853273) | Austin Biological Laboratories | 1985-09-16 |
| PRECEPT TM CARBENICILLIN (K853685) | Austin Biological Laboratories | 1985-09-16 |
| PRECEPT METHICILLIN (K853772) | Austin Biological Laboratories | 1985-09-16 |
| PRECEPT TM MOXALACTAM (K853689) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT TM AMIKACIN (K853686) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT KANAMYCIN (K853684) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT NETILMICIN 32-13 (K853687) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT TM TOBRAMYCIN (K853688) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT ERYTHROMYCIN (K853053) | Austin Biological Laboratories | 1985-08-29 |
| PRECEPT AVGMENTIN (K853263) | Austin Biological Laboratories | 1985-08-29 |
| API UNISCEPT KB (K850347) | Analytical Products, Inc. | 1985-03-26 |
Recalls involving this device
No recalls on record reference this clearance.