FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAICHEM TM CREATINE KINASE REAGENT
K Number: K820644
·
Decision Apr 1, 1982
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
122
Applicant Total
63
Review Days
23
Basic Information
- Device Name
- RAICHEM TM CREATINE KINASE REAGENT
- K Number
- K820644
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- REAGENTS APPLICATIONS, INC.
- Date Received
- March 9, 1982
- Decision Date
- April 1, 1982
- Product Code
- CGS
- 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 |
|---|---|---|---|
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | FDA class 2 | Clinical Chemistry |
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Other Clearances by REAGENTS APPLICATIONS, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K911899 | RAICHEM SPIA C4 REAGENT | May 9, 1991 | Substantially Equivalent |
| K911900 | RAICHEM SPIA C3 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 |