FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC.
K Number: K800897
·
Decision May 8, 1980
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
75
Applicant Total
48
Review Days
20
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Basic Information
- Device Name
- RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC.
- K Number
- K800897
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Icl Scientific
- Date Received
- April 18, 1980
- Decision Date
- May 8, 1980
- Product Code
- DEW
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DEW | Igg, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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| 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 |