Dimension RXL Max with Advia Modular Automation System (Amas)
FDA 510(k) K083339 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK083339
Submission
- Device name
- Dimension RXL Max with Advia Modular Automation System (Amas)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- November 12, 2008
- Decision date
- March 9, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CIC – Cresolphthalein Complexone, Calcium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1145
- Specialty
- Clinical Chemistry
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| K991111 | Buffer Chromogen (R1), Product No. CA110-01, Edta Reagen (R2), Product No. CA110-02CIC · Traditional | A.P. Total Care, Inc. | 05/25/1999SE |
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Questions and answers
When was Dimension RXL Max with Advia Modular Automation System (Amas) cleared by the FDA?
Dimension RXL Max with Advia Modular Automation System (Amas) (K083339) received a 510(k) decision of Substantially Equivalent on March 9, 2009, 117 days after the submission was received.
What is the product code of K083339?
The FDA product code is CIC – Cresolphthalein Complexone, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.