AMYLASE REAGENT #88129— 510(k) K831295

Substantially Equivalent

Hi Chem, Inc.

FDA 510(k) clearance K831295 for AMYLASE REAGENT #88129, Substantially Equivalent on 1983-06-30. Applicant: Hi Chem, Inc.. Device class: 2.

Clearance details

Applicant: Hi Chem, Inc.
Product code: Code KHM
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1983-04-20
Decision date: 1983-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code KHM

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K812447 — AMYLASE REAGENT KIT1981-09-09
K801096 — PERKIN ELMER MODEL 91 AMYLASE REAGENT1980-06-09
K790797 — AMYLASE REAGENT SET1979-07-17
K770400 — REAGENT, AMYLASE LIPASE1977-04-26

More clearances from Hi Chem, Inc.

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K941764 — HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 888081994-05-13
K902673 — HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND1990-07-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.