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FDA 510(k)

EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE

K-Number: K890990 · 1989-04-10

ApplicantHichem Diagnostics
Decision Date1989-04-10
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1989-04-10 under 510(k) number K890990. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE?

EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE is a medical device that received FDA 510(k) clearance on 1989-04-10. The listed applicant is Hichem Diagnostics. The 510(k) number is K890990.

When did EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE receive FDA 510(k) clearance?

EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE received FDA 510(k) clearance on 1989-04-10, under 510(k) number K890990.

Who is the listed applicant for EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE?

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 EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE?

The FDA product code for EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE is CHH.

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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: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, 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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