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FDA 510(k)

HI CHEM WASH CONCENTRATE REAGENT #88805

K-Number: K890578 · 1989-03-10

ApplicantHichem Diagnostics
Decision Date1989-03-10
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HI CHEM WASH CONCENTRATE REAGENT #88805 is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1989-03-10 under 510(k) number K890578. The device is classified under product code JQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI CHEM WASH CONCENTRATE REAGENT #88805?

HI CHEM WASH CONCENTRATE REAGENT #88805 is a medical device that received FDA 510(k) clearance on 1989-03-10. The listed applicant is Hichem Diagnostics. The 510(k) number is K890578.

When did HI CHEM WASH CONCENTRATE REAGENT #88805 receive FDA 510(k) clearance?

HI CHEM WASH CONCENTRATE REAGENT #88805 received FDA 510(k) clearance on 1989-03-10, under 510(k) number K890578.

Who is the listed applicant for HI CHEM WASH CONCENTRATE REAGENT #88805?

The FDA 510(k) record lists Hichem Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI CHEM WASH CONCENTRATE REAGENT #88805?

The FDA product code for HI CHEM WASH CONCENTRATE REAGENT #88805 is JQW.

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Other records listing Hichem Diagnostics 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.

K981794HICHEM CALCIUM REAGENT KITK963383HICHEM ALP/AMP REAGENT KITK953860HICHEM ISE DILUENT KIT 70008K953862HICHEM ISEKCI SOLUTION KIT 70010K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953863HICHEM ISE STANDARDS KIT 70011

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Related Devices (Code: JQW)

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.

K023955BD VIPER INSTRUMENTBecton, Dickinson & COK973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)Zenyx Scientific , Ltd.K9801802700 SAMPLE MANAGERWaters CorporationK970420MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.K970616MINI SAMPLER PROCESSORCavro Scientific Instruments, Inc.K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute Diagnostics

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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