Precinorm TDM Controls
FDA 510(k) K971060 · Boehringer Mannheim Corp.
510(k) numberK971060
Submission
- Device name
- Precinorm TDM Controls
- Applicant
- Boehringer Mannheim Corp.
Concord, CA, US - Received
- March 24, 1997
- Decision date
- July 7, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DIF – Drug Mixture Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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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 Precinorm TDM Controls cleared by the FDA?
Precinorm TDM Controls (K971060) received a 510(k) decision of Substantially Equivalent on July 7, 1997, 105 days after the submission was received.
What is the product code of K971060?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.