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FDA 510(k)

AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM

K-Number: K792279 · 1979-12-06

ApplicantMicromedic Systems
Decision Date1979-12-06
Product CodeCFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTOPAK 12 INSULIN 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 1979-12-06 under 510(k) number K792279. The device is classified under product code CFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM?

AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1979-12-06. The listed applicant is Micromedic Systems. The 510(k) number is K792279.

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

AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM received FDA 510(k) clearance on 1979-12-06, under 510(k) number K792279.

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

The FDA product code for AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM is CFP.

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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: CFP)

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.

K963911ALPCO/MERCODIA INSULIN ELISAAmerican Laboratory Products Co., Ltd.K953084ACCESS ULTRASENSITIVE INSULIN ASSAYBio-Rad Laboratories, Inc.K920109IMX INSULINAbbott LaboratoriesK914820DSL INSULIN RIA (DSL 1600)Diagnostic Systems Laboratories, Inc.K903628AIA-PACK IRITosoh Corp.K901135ENZYMUN TEST(R) INSULINBoehringer 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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