FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRECINORM TDM CONTROLS
K Number: K971060
·
Decision Jul 7, 1997
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
201
Applicant Total
340
Review Days
105
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Basic Information
- Device Name
- PRECINORM TDM CONTROLS
- K Number
- K971060
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boehringer Mannheim Corp.
- Date Received
- March 24, 1997
- Decision Date
- July 7, 1997
- Product Code
- DIF
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | FDA class 1 | Clinical Toxicology |
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|---|---|---|---|
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| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 | Dec 1, 1998 | Substantially Equivalent |
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| K982949 | ELECSYS PSA, MODEL 2010 | Oct 27, 1998 | Substantially Equivalent |