FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LANCER BUN RATE REAGENT KIT
K Number: K812308
·
Decision Aug 31, 1981
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
14
Applicant Total
191
Review Days
14
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Basic Information
- Device Name
- LANCER BUN RATE REAGENT KIT
- K Number
- K812308
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sherwood Medical Co.
- Date Received
- August 17, 1981
- Decision Date
- August 31, 1981
- 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 |
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epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
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| K Number | Device Name | ||
|---|---|---|---|
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| K960632 | KANGAROO FEEDING TUBE PLACMENT STYLET | May 9, 1996 | Substantially Equivalent |
| K955831 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Mar 28, 1996 | Substantially Equivalent |
| K954429 | KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT | Mar 8, 1996 | Unknown |
| K954525 | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER | Jan 19, 1996 | Substantially Equivalent |
| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Dec 15, 1995 | Substantially Equivalent |