Theofast(Tm) Test Package
FDA 510(k) K863475 · 3M Company
510(k) numberK863475
Submission
- Device name
- Theofast(Tm) Test Package
- Applicant
- 3M Company
Mountain View, CA, US - Received
- September 9, 1986
- Decision date
- November 5, 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 |
| K864409 | Immpulse Coated Tube Theophylline Assay ReagentsLER · Traditional | Sclavo, Inc. | 12/22/1986SE |
| 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 |
More from American Diagnostic Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional | 01/28/2025SE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 10/18/2024SE |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490…FRC · Traditional | 09/12/2024SE |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was Theofast(Tm) Test Package cleared by the FDA?
Theofast(Tm) Test Package (K863475) received a 510(k) decision of Substantially Equivalent on November 5, 1986, 57 days after the submission was received.
What is the product code of K863475?
The FDA product code is LER – Fluorescent Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.