Chemstrip Ug
FDA 510(k) K820465 · Biodynamics Corp.
510(k) numberK820465
Submission
- Device name
- Chemstrip Ug
- Applicant
- Biodynamics Corp.
Mchenry, IL, US - Received
- February 22, 1982
- Decision date
- March 11, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K822716 | Universal CentrifugeJPI · Traditional | 09/30/1982SE |
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Questions and answers
When was Chemstrip Ug cleared by the FDA?
Chemstrip Ug (K820465) received a 510(k) decision of Substantially Equivalent on March 11, 1982, 17 days after the submission was received.
What is the product code of K820465?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.