FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KOVA TROL I,II, III HUMAN URINE-DRIED
K Number: K843565
·
Decision Oct 5, 1984
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
48
Review Days
25
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Basic Information
- Device Name
- KOVA TROL I,II, III HUMAN URINE-DRIED
- K Number
- K843565
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Icl Scientific
- Date Received
- September 10, 1984
- Decision Date
- October 5, 1984
- Product Code
- JJW
- 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 |
|---|---|---|---|
| JJW | Urinalysis Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Icl Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K883942 | HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL | Nov 10, 1988 | Substantially Equivalent |
| K833761 | THERAPEUTIC DRUG CONTROL | Jan 13, 1984 | Substantially Equivalent |
| K832823 | ENZYMUNE-TEST TSH | Oct 14, 1983 | Substantially Equivalent |
| K831383 | EVENT-TEST SLIDE | Jun 22, 1983 | Substantially Equivalent |
| K823199 | ENZYME-TEST DIGOXIN | Nov 29, 1982 | Substantially Equivalent |
| K822346 | HISTIMUNE ENZYME-ANA TEST | Oct 8, 1982 | Substantially Equivalent |
| K822777 | THERAPEUTIC DRUG CONTROL | Oct 8, 1982 | Substantially Equivalent |
| K822465 | ENZYMUNE SYSTEM I | Sep 14, 1982 | Substantially Equivalent |
| K821374 | ENZYMUNE-TEST INSULIN | May 28, 1982 | Substantially Equivalent |
| K821097 | SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA | May 5, 1982 | Substantially Equivalent |