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FDA 510(k)

AMES T-3 UPTAKE STRIP TEST

K-Number: K772088 · 1977-12-06

ApplicantMiles Laboratories, Inc.
Decision Date1977-12-06
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMES T-3 UPTAKE STRIP TEST is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1977-12-06 under 510(k) number K772088. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES T-3 UPTAKE STRIP TEST?

AMES T-3 UPTAKE STRIP TEST is a medical device that received FDA 510(k) clearance on 1977-12-06. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K772088.

When did AMES T-3 UPTAKE STRIP TEST receive FDA 510(k) clearance?

AMES T-3 UPTAKE STRIP TEST received FDA 510(k) clearance on 1977-12-06, under 510(k) number K772088.

Who is the listed applicant for AMES T-3 UPTAKE STRIP TEST?

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

What is the FDA product code for AMES T-3 UPTAKE STRIP TEST?

The FDA product code for AMES T-3 UPTAKE STRIP TEST is KHQ.

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Other records listing Miles Laboratories, Inc. as applicant

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K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERK874909MICRO-BUMINTEST REAGENT TABLETSK875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULEK871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTK872120SERALYZER III BLOOD CHEMISTRY ANALYZERK873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

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Related Devices (Code: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.

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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