Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89
FDA 510(k) K993029 · Syva Co.
510(k) numberK993029
Submission
- Device name
- Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89
- Applicant
- Syva Co.
San Jose, CA, US - Received
- September 9, 1999
- Decision date
- January 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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Questions and answers
When was Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89 cleared by the FDA?
Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89 (K993029) received a 510(k) decision of Substantially Equivalent on January 27, 2000, 140 days after the submission was received.
What is the product code of K993029?
The FDA product code is KLS – Enzyme Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.