Total/Ige Theophylline Control Sera
FDA 510(k) K870151 · 3M Company
510(k) numberK870151
Submission
- Device name
- Total/Ige Theophylline Control Sera
- Applicant
- 3M Company
Mountain View, CA, US - Received
- January 13, 1987
- Decision date
- March 12, 1987
- 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 Total/Ige Theophylline Control Sera cleared by the FDA?
Total/Ige Theophylline Control Sera (K870151) received a 510(k) decision of Substantially Equivalent on March 12, 1987, 58 days after the submission was received.
What is the product code of K870151?
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.