FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNI-CHECK REAGENT STRIP
K Number: K924398
·
Decision Dec 23, 1992
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
26
Review Days
114
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Basic Information
- Device Name
- UNI-CHECK REAGENT STRIP
- K Number
- K924398
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diagnostic Solutions, Inc.
- Date Received
- August 31, 1992
- Decision Date
- December 23, 1992
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 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 |
| K921825 | QUICK-CHECK II REAGENT STRIP | Aug 18, 1992 | Substantially Equivalent |
| K800689 | REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- | May 30, 1980 | Substantially Equivalent |
| K800681 | REAGENTS FOR DETERM. CO2 IN HUMAN SERUM | May 30, 1980 | Substantially Equivalent |
| K800672 | SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC | May 28, 1980 | Substantially Equivalent |
| K800674 | SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER | May 28, 1980 | Substantially Equivalent |
| K800687 | REAGENT FOR DETERM. GLUCOSE IN H/SERUM | May 28, 1980 | Substantially Equivalent |
| K800679 | REAGENTS FOR DETERM. ALKALINE PHOSPHATAS | May 28, 1980 | Substantially Equivalent |
| K800685 | REAGENT FOR DETERM. CREATININE IN H/SERU | May 28, 1980 | Substantially Equivalent |
| K800692 | REAGENT FOR DETERM. POTASSIUM/IN HUMAN | May 28, 1980 | Substantially Equivalent |