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FDA 510(k)

ENZYMATIC CHOLESTROL REAGENT SET

K-Number: K855187 · 1986-01-14

ApplicantTechnostics Intl.
Decision Date1986-01-14
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC CHOLESTROL REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Technostics Intl.. It received FDA 510(k) clearance on 1986-01-14 under 510(k) number K855187. 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 ENZYMATIC CHOLESTROL REAGENT SET?

ENZYMATIC CHOLESTROL REAGENT SET is a medical device that received FDA 510(k) clearance on 1986-01-14. The listed applicant is Technostics Intl.. The 510(k) number is K855187.

When did ENZYMATIC CHOLESTROL REAGENT SET receive FDA 510(k) clearance?

ENZYMATIC CHOLESTROL REAGENT SET received FDA 510(k) clearance on 1986-01-14, under 510(k) number K855187.

Who is the listed applicant for ENZYMATIC CHOLESTROL REAGENT SET?

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

What is the FDA product code for ENZYMATIC CHOLESTROL REAGENT SET?

The FDA product code for ENZYMATIC CHOLESTROL REAGENT SET is CHH.

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Other records listing Technostics Intl. 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.

K855188CPK (UV) REAGENT KITK860111URIC ACID REAGENT SETK855190MAGNESIUM REAGENT SETK860110GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SETK860109ENZYMATIC UREA NITROGEN REAGENT SETK860112TOTAL LIPIDS REAGENT SET

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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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