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510(k) K963383

HICHEM ALP/AMP REAGENT KIT by Hichem Diagnostics — Product Code CKF

K963383 is an FDA 510(k) premarket notification submitted by Hichem Diagnostics for the device "HICHEM ALP/AMP REAGENT KIT". The FDA issued a decision of Substantially Equivalent on September 23, 1996. The device falls under product code CKF (Phenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Hichem Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1996
Date Received
August 27, 1996
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 Hichem Diagnostics

  • K981794 — HICHEM CALCIUM REAGENT KIT (July 29, 1998)
  • K953860 — HICHEM ISE DILUENT KIT 70008 (September 6, 1995)
  • K953863 — HICHEM ISE STANDARDS KIT 70011 (September 6, 1995)
  • K953862 — HICHEM ISEKCI SOLUTION KIT 70010 (September 6, 1995)
  • K953861 — HICHEM ISE INTDERNAL REFERENCE KIT 70009 (September 6, 1995)
  • K951751 — HICHEM AST REAGENT KIT (August 2, 1995)
  • K946192 — HICHEM Y-GT REAGENT KIT (May 2, 1995)
  • K946022 — HICHEM LDH/L REAGENT KIT (February 23, 1995)
  • K941433 — HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH (August 2, 1994)
  • K925551 — HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 (April 20, 1993)

Other clearances for product code CKF

  • K072142 — S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST (June 26, 2008)

FDA data resources