510(k) K884596
- Device
- Abbott A-gent Lipase Reagent
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K884596
- Product code
- CHI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-12-06
- Date received
- 1988-11-03
- Regulation
- 862.1465
- Classification name
- Lipase-Esterase, Enzymatic, Photometric, Lipase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BARBARA BOOKER
- Address
- One Abbott Park Rd. Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 3013660430
- 3012240236
- 3005094123
- 8020316
- 2030861
- 2050012
- 3003539867
- 3005333358
- 3003741796
- 2432235
- 1319809
- 2250051
- 8040374
- 3002809144
- 2517506
- 2247288
- 3007662974
- 1827821
- 3004493545
- 3016438761
- 2050010
- 3010825766
- 2032900
- 9681753
- 3014325803
- 9610126
- 1220972
- 1319681
- 3021841051
- 3000148879
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CHI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970905 | SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT | Beckman Instruments, Inc. | 1997-06-04 |
| K961179 | SENTINEL LIPASE LIQUID MODEL 17.401B | Equal Diagnostics, Inc. | 1996-07-19 |
| K952180 | CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS | Beckman Instruments, Inc. | 1995-08-17 |
| K952816 | LIPASE FLEX REAGENT CARTRIDGE | Dupont Medical Products | 1995-07-20 |
| K952647 | IL TEST LIPASE | Instrumentation Laboratory CO | 1995-07-20 |
| K941085 | LIPASE-PS ASSAY PROCEDURE NO. 805 | Sigma Diagnostics, Inc. | 1994-05-17 |
| K923917 | ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY | Nuclear Diagnostics, Inc. | 1994-02-25 |
| K921249 | WAKO AUTOKIT LIPASE-COLOR | Wako Chemicals USA, Inc. | 1992-07-21 |
| K920337 | MILES LIPASE SERA-PAK METHOD | Heraeus Kulzer, Inc. | 1992-03-11 |
| K900827 | COLORIMETRIC CHLORIDE PRODUCT #4314125 | American Research Products Co. | 1990-05-02 |
| K897150 | LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT | Toyo Jozo Co., Ltd. | 1990-02-26 |
| K874027 | LIPASE UV [TOYO] | Advocacy International, Ltd. | 1988-05-27 |
| K875173 | KODAK EKTACHEM DT SLIDES (LIPA) | Eastman Kodak Company | 1988-02-24 |
| K874640 | WAKO(TM) AUTOKIT LIPASE | Wako Chemicals USA, Inc. | 1987-12-22 |
| K862312 | ENZLIPASE, ENZYMATIC LIPASE KIT | Nuclear Diagnostics, Inc. | 1986-09-26 |