Thermal Printer Paper
FDA 510(k) K810549 · Nobel Scientific Industries, Inc.
510(k) numberK810549
Submission
- Device name
- Thermal Printer Paper
- Applicant
- Nobel Scientific Industries, Inc.
Mchenry, IL, US - Received
- March 2, 1981
- Decision date
- April 8, 1981
- 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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| 510(k) | Device | Decision |
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| K854718 | Nsi Astra TM Albumin Reagent Kit Nsi Item # 7926CIX · Traditional | 12/19/1985SE |
| K850944 | Nsi Lysing-D Reagent -4000 MLGGK · Traditional | 03/29/1985SE |
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| K823283 | Flushing Solution · Traditional | 12/03/1982SE |
| K812866 | Astra Reagent Concentrate SystemCGA · Traditional | 12/17/1981SE |
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| K802518 | Bun Reagent Astra 4 & 8 AnalyzersCDN · Traditional | 11/12/1980SE |
| K801346 | Nsi Reagent System for Ortho ELT-8 HemaGIF · Traditional | 08/12/1980SE |
Questions and answers
When was Thermal Printer Paper cleared by the FDA?
Thermal Printer Paper (K810549) received a 510(k) decision of Substantially Equivalent on April 8, 1981, 37 days after the submission was received.
What is the product code of K810549?
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.