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510(k) K911177

ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II by Analytical Control Systems, Inc. — Product Code JJX

K911177 is an FDA 510(k) premarket notification submitted by Analytical Control Systems, Inc. for the device "ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II". The FDA issued a decision of Substantially Equivalent on May 1, 1991. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), 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
May 1, 1991
Date Received
March 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
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)
  • K940397 — ACS O DILVENT PROTEIN DILUTION MATRIX (March 11, 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)

Other clearances for product code JJX

  • K170678 — Beta-CrossLaps CalCheck 5 (April 4, 2017)
  • K162173 — Elecsys CYFRA 21-1 CalCheck 5 (January 12, 2017)
  • K162514 — Multichem A1c (October 26, 2016)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (August 10, 2016)
  • K161522 — LIAISON EBV IgM Serum Control Set (June 30, 2016)
  • K161526 — LIAISON CMV IgM Serum Control Set (June 30, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K152117 — Dropper hsCRP High Sensitivity CRP Control (April 21, 2016)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Ce (July 17, 2015)

FDA data resources