Micro-Plate Reader, MDX-1
FDA 510(k) K894400 · Medix Biotech, Inc.
510(k) numberK894400
Submission
- Device name
- Micro-Plate Reader, MDX-1
- Applicant
- Medix Biotech, Inc.
Foster City, CA, US - Received
- July 19, 1989
- Decision date
- October 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Micro-Plate Reader, MDX-1 cleared by the FDA?
Micro-Plate Reader, MDX-1 (K894400) received a 510(k) decision of Substantially Equivalent on October 23, 1989, 96 days after the submission was received.
What is the product code of K894400?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.