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FDA 510(k)

BIOTEL (TM)/UTI

K-Number: K855238 · 1986-05-09

ApplicantAmerican Diagnostic Corp.
Decision Date1986-05-09
Product CodeJMT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTEL (TM)/UTI is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostic Corp.. It received FDA 510(k) clearance on 1986-05-09 under 510(k) number K855238. The device is classified under product code JMT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTEL (TM)/UTI?

BIOTEL (TM)/UTI is a medical device that received FDA 510(k) clearance on 1986-05-09. The listed applicant is American Diagnostic Corp.. The 510(k) number is K855238.

When did BIOTEL (TM)/UTI receive FDA 510(k) clearance?

BIOTEL (TM)/UTI received FDA 510(k) clearance on 1986-05-09, under 510(k) number K855238.

Who is the listed applicant for BIOTEL (TM)/UTI?

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

What is the FDA product code for BIOTEL (TM)/UTI?

The FDA product code for BIOTEL (TM)/UTI is JMT.

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Other records listing American Diagnostic Corp. as applicant

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Related Devices (Code: JMT)

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.

K251800Healgen® URS Test StripsHealgen Scientific,, LLCK252607AllTest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.K242767Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd.K170118Scanostics UTI Check Application Test SystemTeco DiagnosticsK100024TECO DIAGNOSTICS UTI DETECTION STRIPSTeco DiagnosticsK993850URINALYSIS REAGENT STRIPS (10 PARAMETERS)International Newtech Development, 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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