FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM
K Number: K800683
·
Decision May 28, 1980
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
52
Applicant Total
26
Review Days
63
Basic Information
- Device Name
- REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM
- K Number
- K800683
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- DIAGNOSTIC SOLUTIONS, INC.
- Date Received
- March 26, 1980
- Decision Date
- May 28, 1980
- 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 DIAGNOSTIC SOLUTIONS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K934892 | RELIEF PLUS ONE REAGENT STRIP MODIFICATION | Jan 11, 1994 | Substantially Equivalent |
| K924398 | UNI-CHECK REAGENT STRIP | Dec 23, 1992 | Substantially Equivalent |
| K921825 | QUICK-CHECK II REAGENT STRIP | Aug 18, 1992 | Substantially Equivalent |
| K800681 | REAGENTS FOR DETERM. CO2 IN HUMAN SERUM | May 30, 1980 | Substantially Equivalent |
| K800689 | REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- | May 30, 1980 | Substantially Equivalent |
| K800676 | REAGENTS FOR DETERM. SODIUM IN HUMAN SUM | May 28, 1980 | Substantially Equivalent |
| K800687 | REAGENT FOR DETERM. GLUCOSE IN H/SERUM | May 28, 1980 | Substantially Equivalent |
| K800691 | REAGENT FOR DETERM. LACTATE/DEHYDROGENAS | May 28, 1980 | Substantially Equivalent |
| K800682 | REAGENTS FOR DETERM. CHOLESTEROL/SERUM | May 28, 1980 | Substantially Equivalent |
| K800690 | REAGENT FOR DETERM. INORGANIC/PHOSPHORUS | May 28, 1980 | Substantially Equivalent |