FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHLORIDE TEST SET, CAT.# 0210
K Number: K781635
·
Decision Oct 3, 1978
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
52
Applicant Total
47
Review Days
11
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Basic Information
- Device Name
- CHLORIDE TEST SET, CAT.# 0210
- K Number
- K781635
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Stanbio Laboratory
- Date Received
- September 22, 1978
- Decision Date
- October 3, 1978
- Product Code
- CHJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | FDA class 2 | Clinical Chemistry |
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