MS-2 AUTOMATED URINE SCREENING SYSTEM
FDA 510(k) clearance K781370 · decided 1978-09-20
Clearance details
- K-number
- K781370
- Device name
- MS-2 AUTOMATED URINE SCREENING SYSTEM
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1978-08-08
- Decision date
- 1978-09-20
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- JXA
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Abbott Park, 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 |
|---|---|---|
| OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) (K011043) | Osmetech | 2001-11-30 |
| URISCREEN (K981084) | Diatech Diagnostics,Inc. | 1998-10-07 |
| URINE SCREENING DEVICE (K972676) | Combact Diagnostic Systems , Ltd. | 1998-02-23 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |