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510(k) K940397

ACS O DILVENT PROTEIN DILUTION MATRIX by Analytical Control Systems, Inc. — Product Code JJY

K940397 is an FDA 510(k) premarket notification submitted by Analytical Control Systems, Inc. for the device "ACS O DILVENT PROTEIN DILUTION MATRIX". The FDA issued a decision of Substantially Equivalent on March 11, 1994. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Analytical Control Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1994
Date Received
January 27, 1994
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 Analytical Control Systems, Inc.

  • K961892 — SPECKTIN-LA TEST SET (March 7, 1997)
  • K941115 — ACS CARDIO-TROL CONTROL (July 20, 1994)
  • K940272 — ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL (April 20, 1994)
  • K930477 — ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR (June 7, 1993)
  • K926012 — ACS APCT REAGENT, MODIFIED (April 27, 1993)
  • K925340 — COAGULATION CONTROL CONTAINING HEMOGLOBIN (March 23, 1993)
  • K925906 — NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL (February 18, 1993)
  • K921223 — ACS FREEZE-DRIED APTT REAGENT (August 18, 1992)
  • K921118 — ACS APCT REAGENT (July 28, 1992)
  • K913249 — ACS ULTRA-1 THROMBOPLASTIN (December 4, 1991)

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