Document Chem IV Calibration Verification Test Set
FDA 510(k) K932870 · Casco Standards
510(k) numberK932870
Submission
- Device name
- Document Chem IV Calibration Verification Test Set
- Applicant
- Casco Standards
Yarmouth, ME, US - Received
- June 14, 1993
- Decision date
- August 2, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Document Chem IV Calibration Verification Test Set cleared by the FDA?
Document Chem IV Calibration Verification Test Set (K932870) received a 510(k) decision of Substantially Equivalent on August 2, 1993, 49 days after the submission was received.
What is the product code of K932870?
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.