DETECTION SYSTEM, MS-2 ELECTROCHEMICAL
FDA 510(k) clearance K790297 · decided 1979-04-26
Clearance details
- K-number
- K790297
- Device name
- DETECTION SYSTEM, MS-2 ELECTROCHEMICAL
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1979-02-09
- Decision date
- 1979-04-26
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- JTA
- Device class
- 1
- Regulation number
- 866.2560
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abbott Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BACTEC FUNGAL MEDIUM (K954923) | Becton Dickinson Diagnostic Instrument Systems | 1996-11-21 |
| BACTEC NR-860 (K910835) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-03-11 |
| BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM (K865021) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-02-06 |
| BACTEC NR-730 BACTERIAL DETECTION SYSTEM (K853011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-07-30 |
| RADIOMETRIC BLOOD CULTURE VIALS, AEROBE (K842874) | American Micro Scan | 1984-09-12 |
| BECTEC NR-660 BACTERIAL DETECT SYS (K842279) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-07-20 |
| BAC-T-SCREEN (K833917) | Marion Laboratories, Inc. | 1984-01-13 |
| REVERSE-FLOW SYSTEM (K834264) | Applied Polytechnology, Inc. | 1984-01-13 |
| BACTEC BACTERIAL DETECTION SYSTEM: #5 (K810042) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-01-28 |
| BACTEC BACTERIAL DETECTION SYSTEM (K792575) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1979-12-27 |
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 |