FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN
K Number: K792314
·
Decision Dec 6, 1979
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
23
Applicant Total
48
Review Days
20
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Basic Information
- Device Name
- RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN
- K Number
- K792314
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Icl Scientific
- Date Received
- November 16, 1979
- Decision Date
- December 6, 1979
- Product Code
- FAM
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAM), ordered by most recent decision date.
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VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100
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DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
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ES-3840, VIDEO SIGMOIDOSCOPE
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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 |
| 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 |