FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KING DIAGNOSTICS ALT (GPT) REAGENT
K Number: K922109
·
Decision Jun 4, 1992
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
126
Applicant Total
41
Review Days
30
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
- KING DIAGNOSTICS ALT (GPT) REAGENT
- K Number
- K922109
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1030
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- King Diagnostics, Inc.
- Date Received
- May 5, 1992
- Decision Date
- June 4, 1992
- Product Code
- CKA
- 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 |
|---|---|---|---|
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CKA), ordered by most recent decision date.
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACE ALT REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CARESIDE ALT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TRACE REAGENT LINE FOR THE COBAS MIRA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by King Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933329 | KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT | Oct 22, 1993 | Substantially Equivalent |
| K931834 | KING SODIUM/POTASSIUM STANDARD MODIFIED | Aug 25, 1993 | Substantially Equivalent |
| K931773 | HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) | Aug 16, 1993 | Substantially Equivalent |
| K931326 | KING DIAGNOSTICS CK REAGENT | Jun 15, 1993 | Substantially Equivalent |
| K923129 | KING DIAGNOSTICS GLUCOSE (HK) REAGENT | Nov 2, 1992 | Substantially Equivalent |
| K922969 | KING DIAGNOSTICS UREA NITROGEN REAGENT | Oct 13, 1992 | Substantially Equivalent |
| K922921 | KING DIAGNOSTICS CHLORIDE REAGENT | Oct 5, 1992 | Substantially Equivalent |
| K923927 | KING DIAGNOSTICS MAGNESIUM REAGENT | Sep 30, 1992 | Substantially Equivalent |
| K923091 | KING DIAGNOSTICS GAMMA GT REAGENT | Sep 9, 1992 | Substantially Equivalent |
| K923128 | KING DIAGNOSTICS CHOLESTEROL REAGENT | Sep 9, 1992 | Substantially Equivalent |