Acs O Dilvent Protein Dilution Matrix
FDA 510(k) K940397 · Analytical Control Systems, Inc.
510(k) numberK940397
Submission
- Device name
- Acs O Dilvent Protein Dilution Matrix
- Applicant
- Analytical Control Systems, Inc.
Fishers, IN, US - Received
- January 27, 1994
- Decision date
- March 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Acs O Dilvent Protein Dilution Matrix cleared by the FDA?
Acs O Dilvent Protein Dilution Matrix (K940397) received a 510(k) decision of Substantially Equivalent on March 11, 1994, 43 days after the submission was received.
What is the product code of K940397?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.