FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIGIL PRX CHEMISTRY CONTROL
K Number: K936184
·
Decision Apr 15, 1994
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
11
Review Days
109
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Basic Information
- Device Name
- VIGIL PRX CHEMISTRY CONTROL
- K Number
- K936184
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman-Diagnostic Systems Group
- Date Received
- December 27, 1993
- Decision Date
- April 15, 1994
- Product Code
- JJY
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Beckman-Diagnostic Systems Group
| K Number | Device Name | ||
|---|---|---|---|
| K945522 | I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS | Dec 12, 1994 | Substantially Equivalent |
| K944605 | CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM | Dec 7, 1994 | Substantially Equivalent |
| K944604 | CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS | Dec 7, 1994 | Substantially Equivalent |
| K944606 | CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS | Nov 30, 1994 | Substantially Equivalent |
| K942676 | SYNCHRON CX3 DELTA | Nov 2, 1994 | Substantially Equivalent |
| K934293 | BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT | Jul 6, 1994 | Substantially Equivalent |
| K934068 | BECKMAN DIRECT BILIRUBIN REAGENT | Apr 26, 1994 | Substantially Equivalent |
| K934271 | BECKMAN SYNCHRON LACTATE REAGENT | Nov 9, 1993 | Substantially Equivalent |
| K934046 | BECKMAN CHOLESTEROL REAGENT | Oct 28, 1993 | Substantially Equivalent |
| K934467 | BECKMAN CX AMMONIA/ALCOHOL CONTROL | Oct 27, 1993 | Substantially Equivalent |