Immpulse Coated Tube Theophylline Assay Reagents
FDA 510(k) K864409 · Sclavo, Inc.
510(k) numberK864409
Submission
- Device name
- Immpulse Coated Tube Theophylline Assay Reagents
- Applicant
- Sclavo, Inc.
Sunnyvale, CA, US - Received
- November 10, 1986
- Decision date
- December 22, 1986
- 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 |
| K863475 | Theofast(Tm) Test PackageLER · Traditional | 3M Company | 11/05/1986SE |
| K842585 | Theophylline Kit Fluorescence Polariza-LER · Traditional | Windsor Laboratories, Inc. | 09/26/1984SE |
| K840758 | Immpulse Theophylline Assay ReagentsLER · Traditional | Paragon Diagnostics, Inc. | 04/04/1984SE |
| 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 |
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Questions and answers
When was Immpulse Coated Tube Theophylline Assay Reagents cleared by the FDA?
Immpulse Coated Tube Theophylline Assay Reagents (K864409) received a 510(k) decision of Substantially Equivalent on December 22, 1986, 42 days after the submission was received.
What is the product code of K864409?
The FDA product code is LER – Fluorescent Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.