FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BUN-REATIVE
K Number: K760430
·
Decision Nov 1, 1976
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
14
Applicant Total
340
Review Days
80
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Basic Information
- Device Name
- BUN-REATIVE
- K Number
- K760430
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Boehringer Mannheim Corp.
- Date Received
- August 13, 1976
- Decision Date
- November 1, 1976
- Product Code
- CDS
- 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 |
|---|---|---|---|
| CDS | Electrode, Ion Specific, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
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epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
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CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS
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FDA Class 2
·Clinical Chemistry
Other Clearances by Boehringer Mannheim Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K983047 | ACCU-CHEK HQ SYSTEM | Feb 5, 1999 | Substantially Equivalent |
| K984419 | ELECSYS IGE CALCHECK | Feb 2, 1999 | Substantially Equivalent |
| K984425 | MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR | Jan 20, 1999 | Substantially Equivalent |
| K984372 | ELECSYS CALCHECK TROPONIN T | Dec 14, 1998 | Substantially Equivalent |
| K984105 | ELECSYS TROPONIN T STAT TEST | Dec 8, 1998 | Substantially Equivalent |
| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 | Dec 1, 1998 | Substantially Equivalent |
| K983469 | PRECISET SERUM PROTEINS CALIBRATOR | Nov 25, 1998 | Substantially Equivalent |
| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | Nov 12, 1998 | Substantially Equivalent |
| K982949 | ELECSYS PSA, MODEL 2010 | Oct 27, 1998 | Substantially Equivalent |