FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAI-TROL ELEVATED LIPIDS CONTROL
K Number: K915191
·
Decision Dec 18, 1991
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
63
Review Days
29
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Basic Information
- Device Name
- RAI-TROL ELEVATED LIPIDS CONTROL
- K Number
- K915191
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Reagents Applications, Inc.
- Date Received
- November 19, 1991
- Decision Date
- December 18, 1991
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Reagents Applications, Inc.
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|---|---|---|---|
| K982056 | RAICHEM CO2 REAGENT | Jun 24, 1998 | Substantially Equivalent |
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| K922904 | RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II | Jul 30, 1992 | Substantially Equivalent |
| K913398 | RAICHEM(TM) CREATINE KINASE-MB REAGENT | Sep 25, 1991 | Substantially Equivalent |
| K911900 | RAICHEM SPIA C3 REAGENT | May 9, 1991 | Substantially Equivalent |
| K911899 | RAICHEM SPIA C4 REAGENT | May 9, 1991 | Substantially Equivalent |
| K911898 | RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT | May 8, 1991 | Substantially Equivalent |
| K905084 | RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV | Dec 20, 1990 | Substantially Equivalent |
| K905085 | RAICHEM GGT REAGENT | Dec 20, 1990 | Substantially Equivalent |
| K904175 | RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT | Nov 13, 1990 | Substantially Equivalent |