FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405
K Number: K893692
·
Decision Aug 21, 1989
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
138
Applicant Total
14
Review Days
97
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Basic Information
- Device Name
- EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405
- K Number
- K893692
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1100
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Systems
- Date Received
- May 16, 1989
- Decision Date
- August 21, 1989
- Product Code
- CIT
- 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 |
|---|---|---|---|
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | FDA class 2 | Clinical Chemistry |
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Other Clearances by Diagnostic Systems
| K Number | Device Name | ||
|---|---|---|---|
| K905146 | OLYMPUS URINE PH | Feb 4, 1991 | Substantially Equivalent |
| K893691 | EMDS CREATINE KINASE ITEM NIMBER 65411 | Aug 31, 1989 | Substantially Equivalent |
| K893966 | HDL PRECIPITATING REAGENT | Jul 25, 1989 | Substantially Equivalent |
| K884993 | VISUAL BLOOD GLUCOSE TEST SYSTEM | Dec 29, 1988 | Substantially Equivalent |
| K881116 | EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 | Jun 20, 1988 | Substantially Equivalent |
| K880787 | EASY-TEST LACTIC ACID (LA) | Mar 15, 1988 | Substantially Equivalent |
| K862403 | EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 | Jul 11, 1986 | Substantially Equivalent |
| K854784 | ABSORBANCE (ABS) TEST PAK | Dec 19, 1985 | Substantially Equivalent |
| K853699 | EASY ANALYZER & EASY-TEST REAGENT | Sep 25, 1985 | Substantially Equivalent |
| K853532 | ALCOHOL CALIBRATORS | Sep 16, 1985 | Substantially Equivalent |