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FDA 510(k)

AMYLASE (KINETIC) REAGENT SET

K-Number: K915704 · 1996-06-28

ApplicantTech Intl. Co.
Decision Date1996-06-28
Product CodeCJD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE (KINETIC) REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Tech Intl. Co.. It received FDA 510(k) clearance on 1996-06-28 under 510(k) number K915704. The device is classified under product code CJD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMYLASE (KINETIC) REAGENT SET?

AMYLASE (KINETIC) REAGENT SET is a medical device that received FDA 510(k) clearance on 1996-06-28. The listed applicant is Tech Intl. Co.. The 510(k) number is K915704.

When did AMYLASE (KINETIC) REAGENT SET receive FDA 510(k) clearance?

AMYLASE (KINETIC) REAGENT SET received FDA 510(k) clearance on 1996-06-28, under 510(k) number K915704.

Who is the listed applicant for AMYLASE (KINETIC) REAGENT SET?

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

What is the FDA product code for AMYLASE (KINETIC) REAGENT SET?

The FDA product code for AMYLASE (KINETIC) REAGENT SET is CJD.

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Other records listing Tech Intl. Co. 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.

K915705ACID PHOSPHATASE REAGENT SETK915707AMMONIA REAGENT SETK914158URIC ACID REAGENT SETK915706LIPASE REAGENT SETK914160CHOLESTEROL REGEANT SETK915710AMYLASE (COLORIMETRIC) REAGENT SET

View all 13 devices →

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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