Poli-Mak II
FDA 510(k) K813102 · Pm America, Inc.
510(k) numberK813102
Submission
- Device name
- Poli-Mak II
- Applicant
- Pm America, Inc.
Mchenry, IL, US - Received
- November 3, 1981
- Decision date
- November 24, 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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Questions and answers
When was Poli-Mak II cleared by the FDA?
Poli-Mak II (K813102) received a 510(k) decision of Substantially Equivalent on November 24, 1981, 21 days after the submission was received.
What is the product code of K813102?
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.