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FDA 510(k)

AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM

K-Number: K792662 · 1980-01-17

ApplicantMicromedic Systems
Decision Date1980-01-17
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Micromedic Systems. It received FDA 510(k) clearance on 1980-01-17 under 510(k) number K792662. 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 AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM?

AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1980-01-17. The listed applicant is Micromedic Systems. The 510(k) number is K792662.

When did AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM receive FDA 510(k) clearance?

AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM received FDA 510(k) clearance on 1980-01-17, under 510(k) number K792662.

Who is the listed applicant for AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM?

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

What is the FDA product code for AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM?

The FDA product code for AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM is KHQ.

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Other records listing Micromedic Systems 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.

K923643MEDICOOLK872309MICROMEDIC COMBOSTAT LH/FSH KITK871505AUTOPAK NEONATAL TSH MONOCLONAL IRMA KITK870904MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KITK871008MICROMEDIC NEONATAL T4 KITK870245AUTOPAK TSH MONOCLONAL IRMA KIT

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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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