Home / 510(k) Clearances / K936184

510(k) K936184

VIGIL PRX CHEMISTRY CONTROL by Beckman-Diagnostic Systems Group — Product Code JJY

K936184 is an FDA 510(k) premarket notification submitted by Beckman-Diagnostic Systems Group for the device "VIGIL PRX CHEMISTRY CONTROL". The FDA issued a decision of Substantially Equivalent on April 15, 1994. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Beckman-Diagnostic Systems Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1994
Date Received
December 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Beckman-Diagnostic Systems Group

  • K945522 — I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS (December 12, 1994)
  • K944605 — CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM (December 7, 1994)
  • K944604 — CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS (December 7, 1994)
  • K944606 — CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS (November 30, 1994)
  • K942676 — SYNCHRON CX3 DELTA (November 2, 1994)
  • K934293 — BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT (July 6, 1994)
  • K934068 — BECKMAN DIRECT BILIRUBIN REAGENT (April 26, 1994)
  • K934271 — BECKMAN SYNCHRON LACTATE REAGENT (November 9, 1993)
  • K934046 — BECKMAN CHOLESTEROL REAGENT (October 28, 1993)
  • K934467 — BECKMAN CX AMMONIA/ALCOHOL CONTROL (October 27, 1993)

Other clearances for product code JJY

  • K162530 — Multichem IA Plus (March 31, 2017)
  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)

FDA data resources