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FDA 510(k)

TOTAL LIPIDS REAGENT SET

K-Number: K860112 · 1986-01-24

ApplicantTechnostics Intl.
Decision Date1986-01-24
Product CodeCFD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL LIPIDS 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 1986-01-24 under 510(k) number K860112. The device is classified under product code CFD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL LIPIDS REAGENT SET?

TOTAL LIPIDS REAGENT SET is a medical device that received FDA 510(k) clearance on 1986-01-24. The listed applicant is Technostics Intl.. The 510(k) number is K860112.

When did TOTAL LIPIDS REAGENT SET receive FDA 510(k) clearance?

TOTAL LIPIDS REAGENT SET received FDA 510(k) clearance on 1986-01-24, under 510(k) number K860112.

Who is the listed applicant for TOTAL LIPIDS 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 TOTAL LIPIDS REAGENT SET?

The FDA product code for TOTAL LIPIDS REAGENT SET is CFD.

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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 SETK855185GLUCOSE REAGENT SET

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Related Devices (Code: CFD)

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.

K863073TOTAL LIPIDSJ. D. Assoc.K820500TOTAL LIPID REAGENT SETAnco Medical Reagents & Assoc.K813469LIPID PROFILEBio-Analytics 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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