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FDA 510(k)

AMYLASE REAGENT #88129

K-Number: K831295 · 1983-06-30

ApplicantHi Chem, Inc.
Decision Date1983-06-30
Product CodeKHM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE REAGENT #88129 is the device name listed in this FDA 510(k) record. The listed applicant is Hi Chem, Inc.. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831295. The device is classified under product code KHM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMYLASE REAGENT #88129?

AMYLASE REAGENT #88129 is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Hi Chem, Inc.. The 510(k) number is K831295.

When did AMYLASE REAGENT #88129 receive FDA 510(k) clearance?

AMYLASE REAGENT #88129 received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831295.

Who is the listed applicant for AMYLASE REAGENT #88129?

The FDA 510(k) record lists Hi Chem, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMYLASE REAGENT #88129?

The FDA product code for AMYLASE REAGENT #88129 is KHM.

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Other records listing Hi Chem, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960084HICHEM GLUCOSE/HK REAGENT KITK951818HICHEM ALT REAGENT KITK943684HICHEM ENZYME VERIFIER KITK941764HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808K902673HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STNDK863617ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)

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Related Devices (Code: KHM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K812699AMYLASEPointe Scientific, Inc.,K812447AMYLASE REAGENT KITBioscientificK801096PERKIN ELMER MODEL 91 AMYLASE REAGENTStat EngineeringK790797AMYLASE REAGENT SETAlta Diagnostics, Inc.K770400REAGENT, AMYLASE LIPASEBd Becton Dickinson Vacutainer Systems Preanalytic

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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