Olympus Lactate, OSR6193
FDA 510(k) K042406 · Olympus America, Inc.
510(k) numberK042406
Submission
- Device name
- Olympus Lactate, OSR6193
- Applicant
- Olympus America, Inc.
Irving, TX, US - Received
- September 3, 2004
- Decision date
- December 3, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Olympus Lactate, OSR6193 cleared by the FDA?
Olympus Lactate, OSR6193 (K042406) received a 510(k) decision of Substantially Equivalent on December 3, 2004, 91 days after the submission was received.
What is the product code of K042406?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.