Ciba Corining Acs Theophylline Immunoassay
FDA 510(k) K951169 · Ciba Corning Diagnostics Corp.
510(k) numberK951169
Submission
- Device name
- Ciba Corining Acs Theophylline Immunoassay
- Applicant
- Ciba Corning Diagnostics Corp.
Medfield, MA, US - Received
- March 15, 1995
- Decision date
- June 20, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LGS – Fluorescence Polarization Immunoassay, Theophylline
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3880
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LGS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070810 | Architect I Theophylline Reagents and Calibrators (A-F)LGS · Traditional | Biokit, S.A. | 06/08/2007SE |
| K955567 | Innofluor Theophylline Assay SystemLGS · Traditional | Oxis Intl., Inc. | 01/24/1996SE |
| K953016 | Axsym Theophylline IILGS · Traditional | Abbott Laboratories | 08/24/1995SE |
| K942991 | QMS Theophylline CSLGS · Traditional | Seradyn, Inc. | 09/09/1994SE |
| K932127 | Tdx/Tdxflx & Tdxflx Theophylline Monoclonal IILGS · Traditional | Abbott Laboratories | 08/09/1993SE |
| K922991 | Abbott Tdx/Tdxflx and Tdxflx TheophyllineLGS · Traditional | Abbott Laboratories | 08/27/1992SE |
| K900706 | Modified Accufluor Theophylline Reagent & CalibraLGS · Traditional | Innotron of Oregon, Inc. | 04/12/1990SE |
| K894529 | FPR Theophylline KitLGS · Traditional | Colony Laboratories, Inc. | 09/15/1989SE |
| K871484 | Cobas FP Reagents for Theophylline & CalibratorsLGS · Traditional | Roche Diagnostic Systems, Inc. | 05/28/1987SE |
| K870277 | Monitorx Laserx Theophylline Reagent SetLGS · Traditional | American Monitor Corp. | 02/18/1987SE |
More from American Monitor Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K962559 | Acs Cortisol ImmunoassayJFT · Traditional | 11/05/1996SE |
| K963251 | Ciba Corning ACS;180 DPD AssayJMM · Traditional | 10/15/1996SE |
| K961807 | Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4GLK · Traditional | 07/26/1996SE |
| K961657 | Ciba Corning 400 SystemCHL · Traditional | 06/25/1996SE |
| K962021 | Ciba Corning 348 SystemCHL · Traditional | 06/24/1996SE |
| K962126 | Acs CKMB II ImmunoassayJHS · Traditional | 06/21/1996SE |
| K962041 | Acs LH2 ImmunoassayCEP · Traditional | 06/21/1996SE |
| K961510 | Acs FRT4 ImmunoassayJJX · Traditional | 06/17/1996SE |
| K960246 | Liquid Cardiac Marker 1,2,3 AssayedJJT · Traditional | 04/23/1996SE |
| K955873 | Acs Phenytoin AssayLGR · Traditional | 03/11/1996SE |
Questions and answers
When was Ciba Corining Acs Theophylline Immunoassay cleared by the FDA?
Ciba Corining Acs Theophylline Immunoassay (K951169) received a 510(k) decision of Substantially Equivalent on June 20, 1995, 97 days after the submission was received.
What is the product code of K951169?
The FDA product code is LGS – Fluorescence Polarization Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.