Neochrome(R) III Glucose
FDA 510(k) K892002 · American Monitor Corp.
510(k) numberK892002
Submission
- Device name
- Neochrome(R) III Glucose
- Applicant
- American Monitor Corp.
Indianapolis, IN, US - Received
- March 28, 1989
- Decision date
- June 12, 1989
- 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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| K895423 | Access Chemistry AnalyzerJJE · Traditional | 10/04/1989SE |
| K893137 | Excel (TM) Chemistry AnalyzerJJE · Traditional | 08/10/1989SE |
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| K890312 | Gamma-GlutamyltransferaseJQB · Traditional | 03/24/1989SE |
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Questions and answers
When was Neochrome(R) III Glucose cleared by the FDA?
Neochrome(R) III Glucose (K892002) received a 510(k) decision of Substantially Equivalent on June 12, 1989, 76 days after the submission was received.
What is the product code of K892002?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.