SR1 System Automated Photometric Analyzer
FDA 510(k) K883539 · Serono-Baker Diagnostics, Inc.
510(k) numberK883539
Submission
- Device name
- SR1 System Automated Photometric Analyzer
- Applicant
- Serono-Baker Diagnostics, Inc.
Winchester, VA, US - Received
- August 16, 1988
- Decision date
- October 31, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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| K911912 | SR1 T3 Uptake Enzyme Immunoassay(Mag Solid-Phase)KHQ · Traditional | 09/18/1991SE |
| K911217 | SR1 T4 Enzyme Immunoassay (Magnetic Solid-Phase)KLI · Traditional | 08/16/1991SE |
| K912318 | Estradiol Serozyme Enzyme Immuno (Mag Solid-Phase)CHP · Traditional | 07/25/1991SE |
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Questions and answers
When was SR1 System Automated Photometric Analyzer cleared by the FDA?
SR1 System Automated Photometric Analyzer (K883539) received a 510(k) decision of Substantially Equivalent on October 31, 1988, 76 days after the submission was received.
What is the product code of K883539?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.