FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISE/CI-
K Number: K912647
·
Decision Jul 17, 1991
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
37
Applicant Total
340
Review Days
30
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Basic Information
- Device Name
- ISE/CI-
- K Number
- K912647
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boehringer Mannheim Corp.
- Date Received
- June 17, 1991
- Decision Date
- July 17, 1991
- Product Code
- CGZ
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| CGZ | Electrode, Ion-Specific, Chloride | FDA class 2 | Clinical Chemistry |
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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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| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | Nov 12, 1998 | Substantially Equivalent |
| K982949 | ELECSYS PSA, MODEL 2010 | Oct 27, 1998 | Substantially Equivalent |