Cobas FP Reagents for Theophylline & Calibrators
FDA 510(k) K871484 · Roche Diagnostic Systems, Inc.
510(k) numberK871484
Submission
- Device name
- Cobas FP Reagents for Theophylline & Calibrators
- Applicant
- Roche Diagnostic Systems, Inc.
Belleville, NJ, US - Received
- April 15, 1987
- Decision date
- May 28, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K951169 | Ciba Corining Acs Theophylline ImmunoassayLGS · Traditional | Ciba Corning Diagnostics Corp. | 06/20/1995SE |
| 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 |
| K870277 | Monitorx Laserx Theophylline Reagent SetLGS · Traditional | American Monitor Corp. | 02/18/1987SE |
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Questions and answers
When was Cobas FP Reagents for Theophylline & Calibrators cleared by the FDA?
Cobas FP Reagents for Theophylline & Calibrators (K871484) received a 510(k) decision of Substantially Equivalent on May 28, 1987, 43 days after the submission was received.
What is the product code of K871484?
The FDA product code is LGS – Fluorescence Polarization Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.