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FDA 510(k)

WASH SOLUTION KIT, #88102

K-Number: K802264 · 1980-10-31

ApplicantHi Chem, Inc.
Decision Date1980-10-31
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WASH SOLUTION KIT, #88102 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 1980-10-31 under 510(k) number K802264. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WASH SOLUTION KIT, #88102?

WASH SOLUTION KIT, #88102 is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Hi Chem, Inc.. The 510(k) number is K802264.

When did WASH SOLUTION KIT, #88102 receive FDA 510(k) clearance?

WASH SOLUTION KIT, #88102 received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802264.

Who is the listed applicant for WASH SOLUTION KIT, #88102?

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 WASH SOLUTION KIT, #88102?

The FDA product code for WASH SOLUTION KIT, #88102 is JJF.

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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: JJF)

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.

K052794ETI-MAX 3000DiaSorin, Inc.K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERArkray, Inc.K033734LIGHTCYCLER INSTRUMENT VERSION 1.2Roche Diagnostics Corp.K013654PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZERPrecision Systems, Inc.K012966ROCHE COBAS TAQMAN ANALYZERRoche Molecular Systems, Inc.K993634CARESIDE ANALYZERCareside, Inc.

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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