Alere i Instrument, Alere i Influenza A & B, Alere i Strep A
FDA 510(k) K151690 · Alere Scarborough, Inc.
Submission
- Device name
- Alere i Instrument, Alere i Influenza A & B, Alere i Strep A
- Applicant
- Alere Scarborough, Inc.
Scarborough, ME, US - Received
- June 23, 2015
- Decision date
- July 16, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OOI – Real Time Nucleic Acid Amplification System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.2570
- Specialty
- Clinical Chemistry
The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated…
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Questions and answers
When was Alere i Instrument, Alere i Influenza A & B, Alere i Strep A cleared by the FDA?
Alere i Instrument, Alere i Influenza A & B, Alere i Strep A (K151690) received a 510(k) decision of Substantially Equivalent on July 16, 2015, 23 days after the submission was received.
What is the product code of K151690?
The FDA product code is OOI – Real Time Nucleic Acid Amplification System, a Class II (moderate risk) device regulated under 21 CFR 862.2570.