Unipak 100 Analyzer, 65156 & Chemistr
FDA 510(k) K840883 · Emd Chemicals, Inc.
510(k) numberK840883
Submission
- Device name
- Unipak 100 Analyzer, 65156 & Chemistr
- Applicant
- Emd Chemicals, Inc.
Mchenry, IL, US - Received
- February 27, 1984
- Decision date
- May 16, 1984
- 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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Questions and answers
When was Unipak 100 Analyzer, 65156 & Chemistr cleared by the FDA?
Unipak 100 Analyzer, 65156 & Chemistr (K840883) received a 510(k) decision of Substantially Equivalent on May 16, 1984, 79 days after the submission was received.
What is the product code of K840883?
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.