FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CK-NAC REAGENT
K Number: K834502
·
Decision Feb 27, 1984
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
122
Applicant Total
296
Review Days
68
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CK-NAC REAGENT
- K Number
- K834502
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Roche Diagnostic Systems, Inc.
- Date Received
- December 21, 1983
- Decision Date
- February 27, 1984
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGS), ordered by most recent decision date.
Pointe Scientific Creatinine Kinase (CK) Reagent Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SEKURE Creatine Kinase Assay
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CPK REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Roche Diagnostic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983698 | MODIFICATION TO ABUSCREEN ONLINE BARBITURATES | May 3, 1999 | Substantially Equivalent |
| K983702 | MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES | Feb 11, 1999 | Substantially Equivalent |
| K983704 | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | Feb 10, 1999 | Substantially Equivalent |
| K983556 | ABUSCREEN ONLINE BENZ 300 CALIBRATORS | Dec 15, 1998 | Substantially Equivalent |
| K983555 | ABUSCREEN ONLINE BENZ 200 CALIBRATORS | Dec 15, 1998 | Substantially Equivalent |
| K983697 | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE | Dec 11, 1998 | Substantially Equivalent |
| K983700 | MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE | Dec 11, 1998 | Substantially Equivalent |
| K983701 | MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS | Dec 11, 1998 | Substantially Equivalent |
| K983699 | MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES | Dec 11, 1998 | Substantially Equivalent |
| K983703 | MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE | Dec 11, 1998 | Substantially Equivalent |