Ventrezyme Theophylline Immunoassay
FDA 510(k) K833989 · Vxr, Inc.
510(k) numberK833989
Submission
- Device name
- Ventrezyme Theophylline Immunoassay
- Applicant
- Vxr, Inc.
Mchenry, IL, US - Received
- November 18, 1983
- Decision date
- January 30, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KLS – Enzyme Immunoassay, Theophylline
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3880
- Specialty
- Clinical Toxicology
Other 510(k)s with product code KLS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042520 | Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and IIIKLS · Traditional | Ortho-Clinical Diagnostics, Inc. | 11/30/2004SE |
| K042407 | Emit Caffeine AssayKLS · Traditional | Dade Behring, Inc. | 10/28/2004SE |
| K020740 | Roche Online TheophyllineKLS · Traditional | Roche Diagnostics Corp. | 04/16/2002SE |
| K011771 | Randox TheophyllineKLS · Traditional | Randox Laboratories, Ltd. | 01/17/2002SE |
| K013272 | Acs: 180 and Advia Centaur Theophylline 2 AssayKLS · Special | Bayer Corp. | 10/25/2001SE |
| K011166 | Modification to Emit 2000 Theophylline Assay, Model Osr 4P229KLS · Special | Syva Co., Dade Behring, Inc. | 05/10/2001SE |
| K993029 | Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89KLS · Traditional | Syva Co. | 01/27/2000SE |
| K973583 | Ace Theophylline Reagent, Theo CalibratorsKLS · Traditional | Schiapparelli Biosystems, Inc. | 11/12/1997SE |
| K972495 | Accumeter Theophylline TestKLS · Traditional | Chemtrak, Inc. | 10/10/1997SE |
| K961462 | Cedia Theophylline AssayKLS · Traditional | Boehringer Mannheim Corp. | 06/27/1996SE |
More from Boehringer Mannheim Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K853703 | Ventrezyme T3 Immunoassay T3CDP · Traditional | 10/04/1985SE |
| K853748 | Ventrescreen HCG UrineJHI · Traditional | 10/01/1985SE |
| K841456 | Ventrexyme Eia Controls ImmunoassayJIX · Traditional | 05/21/1984SE |
| K840473 | Ventrezyme T4 Immunoassay T4KLI · Traditional | 04/04/1984SE |
| K833960 | Ventrex Pregnancy Test Kit EnzymeJHI · Traditional | 02/03/1984SE |
| K833878 | Ventrezyme Digoxin Immunoassay DigoxKXT · Traditional | 01/13/1984SE |
| K833909 | Ventrescreen Beta-Hcg Enzyme ImmunoETD · Traditional | 11/21/1983SE |
Questions and answers
When was Ventrezyme Theophylline Immunoassay cleared by the FDA?
Ventrezyme Theophylline Immunoassay (K833989) received a 510(k) decision of Substantially Equivalent on January 30, 1984, 73 days after the submission was received.
What is the product code of K833989?
The FDA product code is KLS – Enzyme Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.