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FDA 510(k)

ACCUFLEX

K-Number: K834590 · 1984-03-19

ApplicantMicromedic Systems
Decision Date1984-03-19
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Micromedic Systems. It received FDA 510(k) clearance on 1984-03-19 under 510(k) number K834590. The device is classified under product code JQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUFLEX?

ACCUFLEX is a medical device that received FDA 510(k) clearance on 1984-03-19. The listed applicant is Micromedic Systems. The 510(k) number is K834590.

When did ACCUFLEX receive FDA 510(k) clearance?

ACCUFLEX received FDA 510(k) clearance on 1984-03-19, under 510(k) number K834590.

Who is the listed applicant for ACCUFLEX?

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 ACCUFLEX?

The FDA product code for ACCUFLEX is JQW.

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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: JQW)

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.

K023955BD VIPER INSTRUMENTBecton, Dickinson & COK973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)Zenyx Scientific , Ltd.K9801802700 SAMPLE MANAGERWaters CorporationK970420MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.K970616MINI SAMPLER PROCESSORCavro Scientific Instruments, Inc.K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute Diagnostics

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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