Theophylline Radioimmunoassay Aria HT System
FDA 510(k) K844170 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK844170
Submission
- Device name
- Theophylline Radioimmunoassay Aria HT System
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- October 25, 1984
- Decision date
- December 11, 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
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| K993029 | Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89KLS · Traditional | Syva Co. | 01/27/2000SE |
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| K972495 | Accumeter Theophylline TestKLS · Traditional | Chemtrak, Inc. | 10/10/1997SE |
| K961462 | Cedia Theophylline AssayKLS · Traditional | Boehringer Mannheim Corp. | 06/27/1996SE |
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Questions and answers
When was Theophylline Radioimmunoassay Aria HT System cleared by the FDA?
Theophylline Radioimmunoassay Aria HT System (K844170) received a 510(k) decision of Substantially Equivalent on December 11, 1984, 47 days after the submission was received.
What is the product code of K844170?
The FDA product code is KLS – Enzyme Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.