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510(k) K833864

AMYLASE REAGENT SET-MODIFIED CARAWAY by Sterling Biochemical, Inc. — Product Code CJA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1984
Date Received
November 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amyloclastic, Amylase
Device Class
Class II
Regulation Number
862.1070
Review Panel
CH
Submission Type

Other clearances by Sterling Biochemical, Inc.

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  • K843332 — ALKALINE PHOSPHATASE REAGENT SET (September 14, 1984)
  • K842521 — AST/GOT REAGENT SET UV RATE (August 12, 1984)
  • K840064 — UREA NITROGEN REAGENT SET (June 14, 1984)
  • K834084 — HYDROXYBUTYRATE DEHYDROGENASE REAGENT (February 4, 1984)
  • K834045 — URIC ACID REAGENT SET (January 30, 1984)
  • K833062 — SERUM CHOLINESTERASE REAGENT SET (November 25, 1983)
  • K831874 — LIPASE REAGENT SET (August 12, 1983)
  • K831415 — LACTIC DEHYDROGENASE REAGENT SET (June 16, 1983)

Other clearances for product code CJA

  • K895555 — MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) (December 22, 1989)
  • K884226 — AMYLASE REAGENT KIT FOR ASTRA SYSTEMS (December 9, 1988)
  • K883059 — WAKO(TM) AUTOKIT AMYLASE (August 30, 1988)
  • K873520 — PARAMAX AMYLASE REAGENT (November 23, 1987)
  • K863052 — ALPHA AMYLASE (September 9, 1986)
  • K862640 — AMYLASE LTS (September 9, 1986)
  • K860530 — AMYLASE REAGENT SET (MODIFIED CARAWAY) (February 28, 1986)
  • K844168 — AMYLASE REAGENT CS-726 (November 20, 1984)
  • K843529 — ASTRA SYSTEMS AMYLASE REAGENT KIT (October 11, 1984)