Encore Ferritin Reagent
FDA 510(k) K850680 · Hybritech, Inc.
510(k) numberK850680
Submission
- Device name
- Encore Ferritin Reagent
- Applicant
- Hybritech, Inc.
San Diego, CA, US - Received
- February 21, 1985
- Decision date
- March 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JMB – Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7360
- Specialty
- Hematology
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Questions and answers
When was Encore Ferritin Reagent cleared by the FDA?
Encore Ferritin Reagent (K850680) received a 510(k) decision of Substantially Equivalent on March 21, 1985, 28 days after the submission was received.
What is the product code of K850680?
The FDA product code is JMB – Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 864.7360.