Delta Trol I & II
FDA 510(k) K853373 · Electro-Nucleonics Laboratories, Inc.
510(k) numberK853373
Submission
- Device name
- Delta Trol I & II
- Applicant
- Electro-Nucleonics Laboratories, Inc.
Columbia, MD, US - Received
- August 12, 1985
- Decision date
- August 23, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJT – Enzyme Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Delta Trol I & II cleared by the FDA?
Delta Trol I & II (K853373) received a 510(k) decision of Substantially Equivalent on August 23, 1985, 11 days after the submission was received.
What is the product code of K853373?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.