FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT QUICKSTART LD-1,#5A30
K Number: K914261
·
Decision Oct 21, 1991
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
288
Review Days
28
Basic Information
- Device Name
- ABBOTT QUICKSTART LD-1,#5A30
- K Number
- K914261
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1445
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- EM DIAGNOSTIC SYSTEMS, INC.
- Date Received
- September 23, 1991
- Decision Date
- October 21, 1991
- Product Code
- JGF
- 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 |
|---|---|---|---|
| JGF | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes | FDA class 2 | Clinical Chemistry |
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Other Clearances by EM DIAGNOSTIC SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K935181 | ASPARTATE AMINOTRANSFERASE (AST) TEST | Jan 27, 1994 | Substantially Equivalent |
| K935180 | ALANINE AMINOTRANSFERASE (ALT) TEST | Jan 13, 1994 | Substantially Equivalent |
| K935178 | EMDS PHOSPHOROUS (PHOS) TEST | Dec 17, 1993 | Substantially Equivalent |
| K935179 | EMDS ALBUMIN (ALB) TEST | Dec 17, 1993 | Substantially Equivalent |
| K935174 | TOTAL PROTEIN TEST (TPRO) | Dec 16, 1993 | Substantially Equivalent |
| K935136 | CHOLESTEROL (CHOL) TEST ITEM NO. 65410 | Dec 16, 1993 | Substantially Equivalent |
| K935175 | LACTATE DEHYDROGENASE (LD) | Dec 16, 1993 | Substantially Equivalent |
| K935177 | GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | Dec 16, 1993 | Substantially Equivalent |
| K935176 | IRON TEST | Dec 16, 1993 | Substantially Equivalent |
| K935183 | EMDS MAGNESIUM (MG) TEST | Dec 9, 1993 | Substantially Equivalent |