FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHLORIDE/TCO2 ANALYZER REAGENTS
K Number: K803013
·
Decision Jan 2, 1981
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
52
Applicant Total
8
Review Days
35
Basic Information
- Device Name
- CHLORIDE/TCO2 ANALYZER REAGENTS
- K Number
- K803013
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- LABORATORY PRODUCTS, INC.
- Date Received
- November 28, 1980
- Decision Date
- January 2, 1981
- Product Code
- CHJ
- 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 |
|---|---|---|---|
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | FDA class 2 | Clinical Chemistry |
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Other Clearances by LABORATORY PRODUCTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K832588 | CIN AGAR | Sep 12, 1983 | Substantially Equivalent |
| K803051 | FLAME PHOTOMETRY REAGENTS | Jan 9, 1981 | Substantially Equivalent |
| K803050 | SPRAY, SYNTHETIC SMEAR | Dec 30, 1980 | Substantially Equivalent |
| K800180 | VARIOUS REAGENTS FOR BLOOD CELL ANALYZER | Mar 19, 1980 | Substantially Equivalent |
| K792482 | CHEMISTRY ANALYZER REAGENTS | Jan 11, 1980 | Substantially Equivalent |
| K792481 | CULTURE PLATES & TUBED MEDIA | Dec 31, 1979 | Substantially Equivalent |
| K792483 | STAINS, COUNTERSTAINS & GEN. PURPOSE | Dec 18, 1979 | Substantially Equivalent |