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510(k) K930477

ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR by Analytical Control Systems, Inc. — Product Code JIS

K930477 is an FDA 510(k) premarket notification submitted by Analytical Control Systems, Inc. for the device "ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR". The FDA issued a decision of Substantially Equivalent on June 7, 1993. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Analytical Control Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1993
Date Received
January 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
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)
  • 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 JIS

  • K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR (August 14, 2012)
  • K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR (May 31, 2006)
  • K060266 — DIMENSION IRON CALIBRATOR (March 9, 2006)
  • K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR (December 23, 2005)
  • K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) (November 7, 2003)
  • K032608 — GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER (October 21, 2003)
  • K032296 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS (August 13, 2003)
  • K030964 — CALIBRATION PLASMA LMW HEPARIN (June 6, 2003)
  • K030546 — CRP (II) CALIBRATORS (June 2, 2003)
  • K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CON (April 11, 2003)

FDA data resources