Ciba Corning ACS;180 DPD Assay
FDA 510(k) K963251 · Ciba Corning Diagnostics Corp.
510(k) numberK963251
Submission
- Device name
- Ciba Corning ACS;180 DPD Assay
- Applicant
- Ciba Corning Diagnostics Corp.
Irvine, CA, US - Received
- August 19, 1996
- Decision date
- October 15, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JMM – Column Chromatography & Color Development, Hydroxyproline
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1400
- Specialty
- Clinical Chemistry
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Questions and answers
When was Ciba Corning ACS;180 DPD Assay cleared by the FDA?
Ciba Corning ACS;180 DPD Assay (K963251) received a 510(k) decision of Substantially Equivalent on October 15, 1996, 57 days after the submission was received.
What is the product code of K963251?
The FDA product code is JMM – Column Chromatography & Color Development, Hydroxyproline, a Class I (low risk) device regulated under 21 CFR 862.1400.