TDX PROCAINAMIDE
FDA 510(k) clearance K834464 · decided 1984-02-03
Clearance details
- K-number
- K834464
- Device name
- TDX PROCAINAMIDE
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1983-12-20
- Decision date
- 1984-02-03
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- LAR
- Device class
- 2
- Regulation number
- 862.3320
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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 |
|---|---|---|
| ONLINE TDM PROCAINAMIDE (K060773) | Roche Diagnostics Corp. | 2006-08-23 |
| DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 (K032573) | Dade Behring, Inc. | 2003-10-31 |
| EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 (K010812) | Syva Co., Dade Behring, Inc. | 2001-04-13 |
| PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K971716) | Bayer Corp. | 1997-06-27 |
| CEDIA N-ACETYLPROCAINAMIDE ASSAY (K963306) | Boehringer Mannheim Corp. | 1996-10-29 |
| CEDIA PROCAINAMIDE ASSAY (K962099) | Boehringer Mannheim Corp. | 1996-08-27 |
| PROCAINAMIDE ENZYME IMMUNOASSAY (K962463) | Diagnostic Reagents, Inc. | 1996-08-14 |
| ABBOTT AXSM PROCAINAMIDE ASSAY (K955444) | Abbott Laboratories | 1996-04-02 |
| OPUS PROCAINAMIDE (K951434) | Behring Diagnostics, Inc. | 1995-07-03 |
| COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR (K942847) | Roche Diagnostic Systems, Inc. | 1994-12-02 |
| OPUS PROCAINAMIDE TEST SYSTEM (K934762) | Pb Diagnostic Systems, Inc. | 1994-07-20 |
| EMIT 2000 PROCAINAMIDE CALIBRATORS (K922914) | Syva Co. | 1992-08-24 |
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 |