URINE SCREENING DEVICE
FDA 510(k) clearance K972676 · decided 1998-02-23
Clearance details
- K-number
- K972676
- Device name
- URINE SCREENING DEVICE
- Applicant
- Combact Diagnostic Systems , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-16
- Decision date
- 1998-02-23
- Days to decision
- 222 days
- Clearance type
- Traditional
- Product code
- JXA
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Rockville, MD, 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 |
|---|---|---|
| OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) (K011043) | Osmetech | 2001-11-30 |
| URISCREEN (K981084) | Diatech Diagnostics,Inc. | 1998-10-07 |
| TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT (K952246) | Tri-Tech, Inc. | 1995-06-20 |
| MULTIPLE (IZON DBS & URINE COLLECTION KIT) (K950257) | Izon Business Products, Inc. | 1995-04-14 |
| MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) (K950221) | Izon Business Products, Inc. | 1995-03-21 |
| MULTIPLE (IZON URINE COLLECTION KIT) (K950246) | Izon Business Products, Inc. | 1995-03-21 |
| CULTURIA MACCONKEY-MUG (K934759) | Clinical Convenience Products, Inc. | 1994-09-09 |
| BAC-T-SCREEN (K924218) | Biomerieux Vitek, Inc. | 1993-02-03 |
| DIASLIDE URINE CULTURING DEVICE (K921045) | Savyon Diagnostics , Ltd. | 1992-09-28 |
| URI-THREE(TM), MODIFICATION (K911846) | Culture Kits, Inc. | 1991-10-04 |
| QUALTURE (K903470) | Future Medical Technologies Intl., Inc. | 1990-12-13 |
| RAPIDEC UR (K894805) | Dms Products, Inc. | 1989-09-26 |
Recalls involving this device
No recalls on record reference this clearance.