URINARY CATHETER SAMPLING KIT
FDA 510(k) clearance K800946 · decided 1980-06-20
Clearance details
- K-number
- K800946
- Device name
- URINARY CATHETER SAMPLING KIT
- Applicant
- Sage Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-04-22
- Decision date
- 1980-06-20
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- KDT
- Device class
- 1
- Regulation number
- 864.3250
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Walker, 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 |
|---|---|---|
| BIOSURE SPECIMEN COLLECTION CONTAINER (K873593) | Biosure, Inc. | 1987-11-25 |
| NOVACYTE-U (K862665) | Xsirius Medical, Inc. | 1986-09-04 |
| BIOSPAL 2400S (K834579) | Hospal Medical Corp. | 1984-02-04 |
| PRESERV PVA FIXATIVE 15ML-FORMALIN PK (K834412) | Preventive Diagnostics Corp. | 1984-01-13 |
| PRESERV PVA FIXATIVE -MALIN PACK (K833660) | Preventive Diagnostics Corp. | 1983-11-28 |
| PROVIAL II #006-010-0201 (K823773) | Dynatech Corp. | 1983-01-21 |
| STOOL-COLLECTION/PRESERVATION KIT (K822870) | American Scientific Products | 1982-11-01 |
| PREGNOPOST (K821621) | M.M. Wolfred, Ph.D. | 1982-07-21 |
| PREFILLED SPECIMEN CONTAINER (K820246) | Sage Products, Inc. | 1982-02-18 |
| FIX-RIGHT 90ML & 180 ML PREFILLED CONT (K811793) | Richard-Allan Medical Ind., Inc. | 1981-07-31 |
| PINLOCK CONTAINER (K770071) | Perkins Mfg. Co. | 1977-02-24 |
Recalls involving this device
No recalls on record reference this clearance.