Multistat III Glucose Test
FDA 510(k) K771471 · Instrumentation Laboratory CO
510(k) numberK771471
Submission
- Device name
- Multistat III Glucose Test
- Applicant
- Instrumentation Laboratory CO
Mchenry, IL, US - Received
- August 4, 1977
- Decision date
- September 12, 1977
- 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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Questions and answers
When was Multistat III Glucose Test cleared by the FDA?
Multistat III Glucose Test (K771471) received a 510(k) decision of Substantially Equivalent on September 12, 1977, 39 days after the submission was received.
What is the product code of K771471?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.