FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOOD-UREA-NITROGEN (BUN) ANALYZER 2
K Number: K761061
·
Decision Jan 25, 1977
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
14
Applicant Total
281
Review Days
68
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Basic Information
- Device Name
- BLOOD-UREA-NITROGEN (BUN) ANALYZER 2
- K Number
- K761061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Beckman Instruments, Inc.
- Date Received
- November 18, 1976
- Decision Date
- January 25, 1977
- 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
Other 510(k) clearances with the same product code (CDS), ordered by most recent decision date.
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
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HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806
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BLOOD UREA NITROGEN (BUN) TESTCARD
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CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS
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Other Clearances by Beckman Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973448 | ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 | Sep 17, 1998 | Substantially Equivalent |
| K982250 | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Jul 14, 1998 | Substantially Equivalent |
| K981403 | IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT | May 8, 1998 | Substantially Equivalent |
| K981354 | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 | May 1, 1998 | Substantially Equivalent |
| K980173 | ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 | Mar 18, 1998 | Substantially Equivalent |
| K974816 | ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 | Feb 20, 1998 | Substantially Equivalent |
| K974564 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT | Feb 17, 1998 | Substantially Equivalent |
| K974110 | IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT | Dec 24, 1997 | Substantially Equivalent |
| K974452 | VIGIL LIPID CONTROL | Dec 17, 1997 | Substantially Equivalent |
| K973932 | BECKMAN CALIBRATOR 2 (CAL2) | Dec 15, 1997 | Substantially Equivalent |