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510(k) K072142

S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST by Alfa Wassermann Diagnostic Technologies, Inc. — Product Code CKF

K072142 is an FDA 510(k) premarket notification submitted by Alfa Wassermann Diagnostic Technologies, Inc. for the device "S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST". The FDA issued a decision of Substantially Equivalent on June 26, 2008. The device falls under product code CKF (Phenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Alfa Wassermann Diagnostic Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2008
Date Received
August 2, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

Other clearances by Alfa Wassermann Diagnostic Technologies, Inc.

  • K170623 — ACE Hemoglobin A1c (HbA1c) Reagent (February 27, 2018)
  • K131975 — ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, A (October 2, 2013)
  • K131351 — ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT (August 15, 2013)
  • K123953 — ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REA (May 2, 2013)
  • K123018 — ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELEC (April 23, 2013)
  • K122757 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES (October 5, 2012)
  • K113389 — ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT (August 10, 2012)
  • K113437 — ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, A (August 6, 2012)
  • K113374 — ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE P (July 13, 2012)
  • K113262 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERID (July 3, 2012)

Other clearances for product code CKF

  • K963383 — HICHEM ALP/AMP REAGENT KIT (September 23, 1996)

FDA data resources