ABBOTT A-GENT LIPASE REAGENT
FDA 510(k) clearance K884596 · decided 1988-12-06
Clearance details
- K-number
- K884596
- Device name
- ABBOTT A-GENT LIPASE REAGENT
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1988-11-03
- Decision date
- 1988-12-06
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- CHI
- Device class
- 1
- Regulation number
- 862.1465
- 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 |
|---|---|---|
| SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT (K970905) | Beckman Instruments, Inc. | 1997-06-04 |
| SENTINEL LIPASE LIQUID MODEL 17.401B (K961179) | Equal Diagnostics, Inc. | 1996-07-19 |
| CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS (K952180) | Beckman Instruments, Inc. | 1995-08-17 |
| IL TEST LIPASE (K952647) | Instrumentation Laboratory CO | 1995-07-20 |
| LIPASE FLEX REAGENT CARTRIDGE (K952816) | Dupont Medical Products | 1995-07-20 |
| LIPASE-PS ASSAY PROCEDURE NO. 805 (K941085) | Sigma Diagnostics, Inc. | 1994-05-17 |
| ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY (K923917) | Nuclear Diagnostics, Inc. | 1994-02-25 |
| WAKO AUTOKIT LIPASE-COLOR (K921249) | Wako Chemicals USA, Inc. | 1992-07-21 |
| MILES LIPASE SERA-PAK METHOD (K920337) | Heraeus Kulzer, Inc. | 1992-03-11 |
| COLORIMETRIC CHLORIDE PRODUCT #4314125 (K900827) | American Research Products Co. | 1990-05-02 |
| LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT (K897150) | Toyo Jozo Co., Ltd. | 1990-02-26 |
| LIPASE UV [TOYO] (K874027) | Advocacy International, Ltd. | 1988-05-27 |
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 |