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FDA 510(k)

AUTOFLUOR SYSTEM

K-Number: K800698 · 1980-05-28

ApplicantCalifornia Immuno Diagnostic, Inc.
Decision Date1980-05-28
Product CodeJZT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOFLUOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is California Immuno Diagnostic, Inc.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K800698. The device is classified under product code JZT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOFLUOR SYSTEM?

AUTOFLUOR SYSTEM is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is California Immuno Diagnostic, Inc.. The 510(k) number is K800698.

When did AUTOFLUOR SYSTEM receive FDA 510(k) clearance?

AUTOFLUOR SYSTEM received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800698.

Who is the listed applicant for AUTOFLUOR SYSTEM?

The FDA 510(k) record lists California Immuno Diagnostic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOFLUOR SYSTEM?

The FDA product code for AUTOFLUOR SYSTEM is JZT.

Related Clinical Trials

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.

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Other records listing California Immuno Diagnostic, 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.

K831623DIA STRIPS SYSTEMK823445ALKPHOR SYSTEM

Related Devices (Code: JZT)

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.

K962499ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READERBartels, Inc.K883349QLIA IMMUNOCHEMISTRY SYSTEMBd Becton Dickinson Vacutainer Systems PreanalyticK882677STAT-20 FLUOROMETERWeaver MedicalK864699FLUORESCENCE CONCENTRATION ANALYZER (FCA)Pandex Laboratories, Inc.K863434THE FIAX 5000 FLUOROMETERWhittaker Bioproducts, Inc.K862674PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEMHybritech, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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