FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL
K Number: K883942
·
Decision Nov 10, 1988
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
48
Review Days
52
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Basic Information
- Device Name
- HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL
- K Number
- K883942
- 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 19, 1988
- Decision Date
- November 10, 1988
- Product Code
- JJY
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 Icl Scientific
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K821097 | SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA | May 5, 1982 | Substantially Equivalent |