FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VES-TEC/VES-MATIC
K Number: K854223
·
Decision Apr 4, 1986
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
23
Applicant Total
3
Review Days
168
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
- VES-TEC/VES-MATIC
- K Number
- K854223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1020
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Marvic Interpharma, Inc.
- Date Received
- October 18, 1985
- Decision Date
- April 4, 1986
- Product Code
- CKB
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| CKB | Acid Phosphatase, Naphthyl Phosphate | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CKB), ordered by most recent decision date.
DRI-STAT ACID PHOSPHATASE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OLYMPUS ACID PHOSPHATASE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry