FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIQUID CHEMISTRY CONTROL, LEVEL I
K Number: K870684
·
Decision Apr 6, 1987
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
22
Review Days
46
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Basic Information
- Device Name
- LIQUID CHEMISTRY CONTROL, LEVEL I
- K Number
- K870684
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- U. S. Diagnostics, Inc.
- Date Received
- February 19, 1987
- Decision Date
- April 6, 1987
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by U. S. Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K110435 | EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM | Sep 21, 2011 | Substantially Equivalent |
| K082201 | G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A | Feb 20, 2009 | Substantially Equivalent |
| K061431 | EASYGLUCO, MODEL IGM-0002 G2 | Jan 12, 2007 | Substantially Equivalent |
| K051651 | G4, MODEL IGM-0004 | Apr 14, 2006 | Substantially Equivalent |
| K870596 | PROTHROMBIN TIME TEST | Apr 20, 1987 | Substantially Equivalent |
| K870685 | COAGULATION CONTROL, LEVEL I | Apr 20, 1987 | Substantially Equivalent |
| K870687 | COAGULATION CONTROL, LEVEL III | Apr 20, 1987 | Substantially Equivalent |
| K870686 | COAGULATION CONTROL, LEVEL II | Apr 20, 1987 | Substantially Equivalent |
| K871283 | CYANMETHEMOGLOBIN STANDARD | Apr 15, 1987 | Substantially Equivalent |
| K870737 | U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL | Apr 13, 1987 | Substantially Equivalent |