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FDA 510(k)

ISO-DATA IMMUNOASSAY NETWORK SYSTEM

K-Number: K843365 · 1984-09-27

ApplicantIso-Data, Inc.
Decision Date1984-09-27
Product CodeJQP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISO-DATA IMMUNOASSAY NETWORK SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Iso-Data, Inc.. It received FDA 510(k) clearance on 1984-09-27 under 510(k) number K843365. The device is classified under product code JQP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISO-DATA IMMUNOASSAY NETWORK SYSTEM?

ISO-DATA IMMUNOASSAY NETWORK SYSTEM is a medical device that received FDA 510(k) clearance on 1984-09-27. The listed applicant is Iso-Data, Inc.. The 510(k) number is K843365.

When did ISO-DATA IMMUNOASSAY NETWORK SYSTEM receive FDA 510(k) clearance?

ISO-DATA IMMUNOASSAY NETWORK SYSTEM received FDA 510(k) clearance on 1984-09-27, under 510(k) number K843365.

Who is the listed applicant for ISO-DATA IMMUNOASSAY NETWORK SYSTEM?

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

What is the FDA product code for ISO-DATA IMMUNOASSAY NETWORK SYSTEM?

The FDA product code for ISO-DATA IMMUNOASSAY NETWORK SYSTEM is JQP.

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Other records listing Iso-Data, Inc. 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.

K872429ISO-DATA 100 SERIES GAMMA COUNTERK872430ISO-DATA 500 SERIES GAMMA COUNTERK843434ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.K810631DPM CALCULATORK780813IDI GDR DATA REDUCTION SYSTEMK780790IDI 200 GAMMA COUNTER

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Related Devices (Code: JQP)

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.

K113007BIONIME DIABETES MANAGEMENT SYSTEM VI.0Bionime CorporationK983468FASTTAKE ADAPTER, MODEL # P/N 020-072-01Selfcare, Inc.K964460THE ROBOLITEShai Syg Motion and Innovations, Ltd.K953652PRENVAL IBase Ten Systems, Inc.K934111MR7000 WITH TIME MANAGER SOFTWARE (TMS)Dynatech Laboratories, Inc.K923316EXPRESSO CARTRIDGEBio-Rad Laboratories, Inc.

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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