Glu(God) Reagent
FDA 510(k) K851992 · Alpkem Corp.
510(k) numberK851992
Submission
- Device name
- Glu(God) Reagent
- Applicant
- Alpkem Corp.
Clackamas, OR, US - Received
- May 7, 1985
- Decision date
- May 29, 1985
- 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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| K890337 | Triglycerides - Gpo ReagentCDT · Traditional | 03/09/1989SE |
| K890336 | Glucose (God) ReagentCGA · Traditional | 02/27/1989SE |
| K890335 | Sodium Hydroxide Solution, Creatinine Reag./Dilu.CGE · Traditional | 02/17/1989SE |
| K890333 | Albumin ReagentEIX · Traditional | 02/17/1989SE |
| K890332 | RFA/2 Rapid Flow Analyzer W/ComputerJJC · Traditional | 02/17/1989SE |
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Questions and answers
When was Glu(God) Reagent cleared by the FDA?
Glu(God) Reagent (K851992) received a 510(k) decision of Substantially Equivalent on May 29, 1985, 22 days after the submission was received.
What is the product code of K851992?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.