FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAICHEM(TM) AMMONIA REAGENT
K Number: K864706
·
Decision Jan 5, 1987
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
29
Applicant Total
63
Review Days
34
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Basic Information
- Device Name
- RAICHEM(TM) AMMONIA REAGENT
- K Number
- K864706
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1065
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Reagents Applications, Inc.
- Date Received
- December 2, 1986
- Decision Date
- January 5, 1987
- Product Code
- JIF
- 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 |
|---|---|---|---|
| JIF | Enzymatic Method, Ammonia | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIF), ordered by most recent decision date.
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DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
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DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
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SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
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AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
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Other Clearances by Reagents Applications, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982056 | RAICHEM CO2 REAGENT | Jun 24, 1998 | Substantially Equivalent |
| K972853 | CHOLESTEROL RAPID LIQUID REAGENT | Sep 24, 1997 | Substantially Equivalent |
| K922904 | RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II | Jul 30, 1992 | Substantially Equivalent |
| K915191 | RAI-TROL ELEVATED LIPIDS CONTROL | Dec 18, 1991 | 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 |