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FDA 510(k)

AUTOPAK ESTRIOL TEST DELIVERY SYSTEM

K-Number: K821678 · 1982-06-24

ApplicantMicromedic Systems
Decision Date1982-06-24
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTOPAK ESTRIOL 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 1982-06-24 under 510(k) number K821678. The device is classified under product code CGI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOPAK ESTRIOL TEST DELIVERY SYSTEM?

AUTOPAK ESTRIOL TEST DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1982-06-24. The listed applicant is Micromedic Systems. The 510(k) number is K821678.

When did AUTOPAK ESTRIOL TEST DELIVERY SYSTEM receive FDA 510(k) clearance?

AUTOPAK ESTRIOL TEST DELIVERY SYSTEM received FDA 510(k) clearance on 1982-06-24, under 510(k) number K821678.

Who is the listed applicant for AUTOPAK ESTRIOL 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 ESTRIOL TEST DELIVERY SYSTEM?

The FDA product code for AUTOPAK ESTRIOL TEST DELIVERY SYSTEM is CGI.

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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 KITK871008MICROMEDIC NEONATAL T4 KITK870904MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KITK871505AUTOPAK NEONATAL TSH MONOCLONAL IRMA KITK870245AUTOPAK TSH MONOCLONAL IRMA KIT

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Related Devices (Code: CGI)

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.

K974721UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.K962875ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIADiagnostic Systems Laboratories, Inc.K955356ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOLDiagnostic Systems Laboratories, Inc.K932989COAT-A-COUNT FREE ESTRIOLDiagnostic Products Corp.K944490AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KITWallac OYK920576AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOLEastman Kodak Company

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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