Autoreader 2
FDA 510(k) K103532 · Trek Diagnostic Systems
510(k) numberK103532
Submission
- Device name
- Autoreader 2
- Applicant
- Trek Diagnostic Systems
Cleveland, OH, US - Received
- December 1, 2010
- Decision date
- August 26, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LRG – Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
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| K111429 | Sensititre (R) HP Mic Susceptibility Plate with Cefaroline (0.004-8UG/ML) and the…JWY · Traditional | 08/18/2011SE |
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| K093741 | Sensitive Haemophilus Influenzae, Streptococcus Pneumonia, (HP) Mic Susceptibility PlatesJWY · Traditional | 02/25/2010SE |
| K093865 | Sensititre 18-24HR Susceptibility PlatesJWY · Traditional | 02/17/2010SE |
| K092445 | Sensititre 18-24 Hour Susceptibility PlatesJWY · Traditional | 12/16/2009SE |
Questions and answers
When was Autoreader 2 cleared by the FDA?
Autoreader 2 (K103532) received a 510(k) decision of Substantially Equivalent on August 26, 2011, 268 days after the submission was received.
What is the product code of K103532?
The FDA product code is LRG – Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.