FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KOVA TROL III
K Number: K780482
·
Decision May 3, 1978
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
48
Review Days
37
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- KOVA TROL III
- K Number
- K780482
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Icl Scientific
- Date Received
- March 27, 1978
- Decision Date
- May 3, 1978
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJW), ordered by most recent decision date.
UA-Cellular Complete
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AUTION CHECK PLUS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
UA-CELLULAR COMPLETE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Icl Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K883942 | HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL | Nov 10, 1988 | Substantially Equivalent |
| K843565 | KOVA TROL I,II, III HUMAN URINE-DRIED | Oct 5, 1984 | 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 |