Elecsys Calcheck Estradiol
FDA 510(k) K970148 · Boehringer Mannheim Corp.
510(k) numberK970148
Submission
- Device name
- Elecsys Calcheck Estradiol
- Applicant
- Boehringer Mannheim Corp.
Concord, CA, US - Received
- January 15, 1997
- Decision date
- February 10, 1997
- 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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| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
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Questions and answers
When was Elecsys Calcheck Estradiol cleared by the FDA?
Elecsys Calcheck Estradiol (K970148) received a 510(k) decision of Substantially Equivalent on February 10, 1997, 26 days after the submission was received.
What is the product code of K970148?
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.