Micro-Eia Theophylline Test Kit Monoclonal
FDA 510(k) K855227 · Bioclinical Systems, Inc.
510(k) numberK855227
Submission
- Device name
- Micro-Eia Theophylline Test Kit Monoclonal
- Applicant
- Bioclinical Systems, Inc.
St.Louis, MO, US - Received
- December 30, 1985
- Decision date
- April 11, 1986
- 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 |
|---|---|---|
| K950196 | Culture Media, for Isolation of Pathogenic NeisseriaJTY · Traditional | 06/30/1995SE |
| K945911 | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton AgarsJTZ · Traditional | 04/04/1995SE |
| K933122 | Microbiological Culture Media,Martin Lewis AgarJTY · Traditional | 02/09/1994SE |
| K933121 | Microbiological Culture Media,Chocolate AgarJTY · Traditional | 02/03/1994SE |
| K873086 | Round 1JXA · Traditional | 08/24/1987SE |
| K860334 | Visi-Check HLH Test MonoclonalCEP · Traditional | 04/21/1986SE |
| K860333 | Micro-Elisa HLH Test Kit MonoclonalCEP · Traditional | 04/21/1986SE |
| K854059 | Micro-Elisa HCG Est Kit Visi-Check HCG Test Kit NoJHI · Traditional | 01/13/1986SE |
| K854379 | Micro-Elisa TSH Test Kit-Visi-Check TSH Test KitJLW · Traditional | 01/07/1986SE |
| K850257 | BCS Glucose Colorimetric TestCGA · Traditional | 03/05/1985SE |
Questions and answers
When was Micro-Eia Theophylline Test Kit Monoclonal cleared by the FDA?
Micro-Eia Theophylline Test Kit Monoclonal (K855227) received a 510(k) decision of Substantially Equivalent on April 11, 1986, 102 days after the submission was received.
What is the product code of K855227?
The FDA product code is KLS – Enzyme Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.