Immpulse Theophylline Assay Reagents
FDA 510(k) K840758 · Paragon Diagnostics, Inc.
510(k) numberK840758
Submission
- Device name
- Immpulse Theophylline Assay Reagents
- Applicant
- Paragon Diagnostics, Inc.
Walker, MI, US - Received
- February 23, 1984
- Decision date
- April 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LER – Fluorescent Immunoassay, Theophylline
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3880
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LER
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942192 | Theophylline Fpia Reagent Set and CalibratorsLER · Traditional | Sigma Diagnostics, Inc. | 07/13/1994SE |
| K905521 | Cedia(R) Theophylline Assay/ModificationLER · Traditional | Microgenics Corp. | 12/26/1990SE |
| K882570 | Turbox Theophylline AssayLER · Traditional | Unipath , Ltd. | 11/10/1988SE |
| K864409 | Immpulse Coated Tube Theophylline Assay ReagentsLER · Traditional | Sclavo, Inc. | 12/22/1986SE |
| K863475 | Theofast(Tm) Test PackageLER · Traditional | 3M Company | 11/05/1986SE |
| K842585 | Theophylline Kit Fluorescence Polariza-LER · Traditional | Windsor Laboratories, Inc. | 09/26/1984SE |
| K833070 | TDX TheophyllineLER · Traditional | Abbott Laboratories | 11/14/1983SE |
| K831514 | Amwa Tda Theophylline TestLER · Traditional | Miles Laboratories, Inc. | 06/30/1983SE |
| K823576 | Cobas Standard for Total ProteinLER · Traditional | Hoffmann-La Roche, Inc. | 01/07/1983SE |
| K820397 | Amerifluor Theophylline Fluorescent ImmLER · Traditional | American Diagnostic Corp. | 03/02/1982SE |
More from American Diagnostic Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K841162 | Immpulse Gentamicin Assay ReagentsLCQ · Traditional | 05/02/1984SE |
| K841161 | Immpulse Amikacin Assay ReagentsKLQ · Traditional | 05/02/1984SE |
| K840852 | Immpulse T4 Assay ReagentsCDX · Traditional | 04/18/1984SE |
| K840847 | Immpulse Tobramycin Assay ReagentsLCR · Traditional | 04/04/1984SE |
| K840853 | Immpulse TBC Assay ReagentsKHQ · Traditional | 04/01/1984SE |
| K834070 | Immpulse SystemJZT · Traditional | 03/23/1984SE |
Questions and answers
When was Immpulse Theophylline Assay Reagents cleared by the FDA?
Immpulse Theophylline Assay Reagents (K840758) received a 510(k) decision of Substantially Equivalent on April 4, 1984, 41 days after the submission was received.
What is the product code of K840758?
The FDA product code is LER – Fluorescent Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.