Quickrate Reaction Rate Analyzer
FDA 510(k) K780972 · Olympus Corp.
510(k) numberK780972
Submission
- Device name
- Quickrate Reaction Rate Analyzer
- Applicant
- Olympus Corp.
Mchenry, IL, US - Received
- June 12, 1978
- Decision date
- August 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJI – Analyzer, Enzyme, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2500
- Specialty
- Clinical Chemistry
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Questions and answers
When was Quickrate Reaction Rate Analyzer cleared by the FDA?
Quickrate Reaction Rate Analyzer (K780972) received a 510(k) decision of Substantially Equivalent on August 14, 1978, 63 days after the submission was received.
What is the product code of K780972?
The FDA product code is JJI – Analyzer, Enzyme, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2500.