ABBOTT IMX2 ANALYER
FDA 510(k) clearance K931970 · decided 1993-06-16
Clearance details
- K-number
- K931970
- Device name
- ABBOTT IMX2 ANALYER
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1993-04-22
- Decision date
- 1993-06-16
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- JJI
- Device class
- 1
- Regulation number
- 862.2500
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| CODA AUTOMATED EIA ANALYZER (K972024) | Bio-Rad | 1997-07-30 |
| ABBOTT IMX 2 ANALYZER (K944731) | Abbott Laboratories | 1994-12-19 |
| RADIAS AUTOMATED IMMUNOASSAY SYSTEM (K930898) | Bio-Rad | 1993-04-21 |
| ANALYZER, IMPACT 100 (K790073) | Gilford Instrument Laboratories, Inc. | 1979-02-22 |
| QUICKRATE REACTION RATE ANALYZER (K780972) | Olympus Corp. | 1978-08-14 |
| MINISTAT-S CHEMISTRY ANALYZER (K771591) | Biokinetix Corp. | 1977-09-20 |
| LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE (K770401) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-26 |
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 |