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510(k) K790797

AMYLASE REAGENT SET by Alta Diagnostics, Inc. — Product Code KHM

K790797 is an FDA 510(k) premarket notification submitted by Alta Diagnostics, Inc. for the device "AMYLASE REAGENT SET". The FDA issued a decision of Substantially Equivalent on July 17, 1979. The device falls under product code KHM (Nephelometric, Amylase), a Class II device regulated under 21 CFR 862.1070. Alta Diagnostics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1979
Date Received
April 24, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Alta Diagnostics, Inc.

  • K800327 — MAGNESIUM REAGENT (March 25, 1980)
  • K792545 — URIC ACID KIT (January 29, 1980)
  • K792546 — FETAL CHECK (December 18, 1979)
  • K790796 — LIPASE REAGENT SET (July 17, 1979)

Other clearances for product code KHM

  • K831295 — AMYLASE REAGENT #88129 (June 30, 1983)
  • K812699 — AMYLASE (October 6, 1981)
  • K812447 — AMYLASE REAGENT KIT (September 9, 1981)
  • K801096 — PERKIN ELMER MODEL 91 AMYLASE REAGENT (June 9, 1980)
  • K770400 — REAGENT, AMYLASE LIPASE (April 26, 1977)

FDA data resources