TDX REA LACTIC ACID
FDA 510(k) clearance K861741 · decided 1986-07-07
Clearance details
- K-number
- K861741
- Device name
- TDX REA LACTIC ACID
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1986-05-06
- Decision date
- 1986-07-07
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- KHP
- Device class
- 1
- Regulation number
- 862.1450
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| PICCOLO LACTATE TEST SYSTEM (K130113) | Abaxis, Inc. | 2013-03-11 |
| RAPIDPOINT 500 BLOOD GAS ANALYER (K113216) | Siemens Healthcare Diagnostics | 2012-05-03 |
| NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM (K112955) | Nova Biomedical Corporation | 2012-01-05 |
| I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE (K112430) | Abbott Pont of Care, Inc. | 2011-12-20 |
| NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS (K100602) | Nova Biomedical Corp. | 2011-08-17 |
| EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE (K093297) | Epocal, Inc. | 2010-06-09 |
| IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE (K013938) | Diametrics Medical, Inc. | 2002-01-28 |
| I-STAT SYSTEM (K011478) | I-Stat Corp. | 2001-07-02 |
| LACTATE PRO SYSTEM (K980908) | Kdk Corp. | 1998-09-11 |
| I-STAT LACTATE TEST (K982071) | I-Stat Corp. | 1998-06-29 |
| LACTEST I (K971944) | Jwt, Inc. | 1997-12-17 |
| ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR (K951331) | Boehringer Mannheim Corp. | 1995-08-11 |
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 |