POC-AS10 Auto Sampler
FDA 510(k) K092817 · Otsuka Pharmaceutical Co., Ltd.
510(k) numberK092817
Submission
- Device name
- POC-AS10 Auto Sampler
- Applicant
- Otsuka Pharmaceutical Co., Ltd.
North Attleboro, MA, US - Received
- September 14, 2009
- Decision date
- March 9, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSQ – Test, Urea (Breath Or Blood)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3110
- Specialty
- Microbiology
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| K220494 | BreathID Hp Lab System, BreathID Smart SystemMSQ · Special | Meridian Bioscience Israel , Ltd. | 06/23/2022SE |
| K193610 | BreathID Smart SystemMSQ · Special | Exalenz Bioscience , Ltd. | 02/06/2020SE |
| K173777 | BreathID Hp Lab SystemMSQ · Traditional | Exalenz Bioscience , Ltd. | 03/08/2018SE |
| K173772 | BreathID Hp SystemMSQ · Traditional | Exalenz Bioscience , Ltd. | 03/08/2018SE |
| K162150 | BreathID Hp Lab SystemMSQ · Traditional | Exalenz Bioscience , Ltd. | 10/31/2016SE |
| K130524 | Breathid HP SystemMSQ · Traditional | Exalenz Bioscience , Ltd. | 05/22/2013SE |
| K093834 | Crit-Line Anemia Management SoftwareMSQ · Traditional | Hema Metrics, LLC | 09/29/2010SE |
| K041148 | Pocone Infrared SpectrophotometerMSQ · Traditional | Otsuka Pharmaceutical Co., Ltd. | 07/15/2004SE |
More from Otsuka Pharmaceutical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K052716 | Rapirun H. Pylori Antibody Detection KitLYR · Traditional | 11/16/2006SE |
| K041148 | Pocone Infrared SpectrophotometerMSQ · Traditional | 07/15/2004SE |
| K013371 | UBIT-IR300 Infrared Spectrometry SystemJJQ · Traditional | 12/21/2001SE |
| K001032 | Rlp-Cholesterol Immunoseparation AssayCHH · Traditional | 07/24/2000SE |
| K991083 | RLP Cholesterol Immunoseparation AssayCHH · Traditional | 08/20/1999SE |
Questions and answers
When was POC-AS10 Auto Sampler cleared by the FDA?
POC-AS10 Auto Sampler (K092817) received a 510(k) decision of Substantially Equivalent on March 9, 2010, 176 days after the submission was received.
What is the product code of K092817?
The FDA product code is MSQ – Test, Urea (Breath Or Blood), a Class I (low risk) device regulated under 21 CFR 866.3110.