Thermomixer S213-PHOTOANALYZER S263
FDA 510(k) K831649 · Texas Intl. Laboratories, Inc.
510(k) numberK831649
Submission
- Device name
- Thermomixer S213-PHOTOANALYZER S263
- Applicant
- Texas Intl. Laboratories, Inc.
Mchenry, IL, US - Received
- May 23, 1983
- Decision date
- August 24, 1983
- 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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| K900685 | Clot 2 Semiautomatic Coagulation AnalyzerKQG · Traditional | 04/16/1990SE |
| K900684 | RDW and MPV Indices on Hemat 12GKZ · Traditional | 04/16/1990SE |
| K884006 | Hemat 12GKZ · Traditional | 12/05/1988SE |
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| K853722 | PLT-4 Platelet AnalyzerGKL · Traditional | 01/17/1986SE |
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Questions and answers
When was Thermomixer S213-PHOTOANALYZER S263 cleared by the FDA?
Thermomixer S213-PHOTOANALYZER S263 (K831649) received a 510(k) decision of Substantially Equivalent on August 24, 1983, 93 days after the submission was received.
What is the product code of K831649?
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.