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FDA 510(k)

URINE DIAGNOSTIC REAGENT STRIPS

K-Number: K862806 · 1986-12-04

ApplicantAmatech International, Inc.
Decision Date1986-12-04
Product CodeJJB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINE DIAGNOSTIC REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Amatech International, Inc.. It received FDA 510(k) clearance on 1986-12-04 under 510(k) number K862806. The device is classified under product code JJB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE DIAGNOSTIC REAGENT STRIPS?

URINE DIAGNOSTIC REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1986-12-04. The listed applicant is Amatech International, Inc.. The 510(k) number is K862806.

When did URINE DIAGNOSTIC REAGENT STRIPS receive FDA 510(k) clearance?

URINE DIAGNOSTIC REAGENT STRIPS received FDA 510(k) clearance on 1986-12-04, under 510(k) number K862806.

Who is the listed applicant for URINE DIAGNOSTIC REAGENT STRIPS?

The FDA 510(k) record lists Amatech International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URINE DIAGNOSTIC REAGENT STRIPS?

The FDA product code for URINE DIAGNOSTIC REAGENT STRIPS is JJB.

Related Clinical Trials

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.

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Other records listing Amatech International, Inc. 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.

K875049MD STRIPS BGK872704AMASTIM 2000

Related Devices (Code: JJB)

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.

K943436URINE REAGENT STRIPS-8 PARAMETERSTeco DiagnosticsK943008BIOSCAN REAGENT STRIPSGenesis Labs, Inc.K873553WAKO(TM) PRETEST 8AWako Chemicals USA, Inc.K833521REAGENT TESTS STRIP COMBINATIONSSyn-Kit, 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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